Maquet Cardiovascular Us Sales, LLC
Wayne, NJ, US
Maquet Cardiovascular Us Sales, Llc appears in FDA device records in Wayne, NJ. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 199 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Maquet Cardiovascular Us Sales, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Getinge Usa Sales Incregistration, enforcement report, recall
- Maquet Medical Systems, Usaenforcement report, recall
- Maquet, Inc.registration, 510(k), enforcement report, recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Maquet Cardiovascular Us Sales, LLC between 2004 and 2022. The busiest year on record is 2004, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2007 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K214120 | GSS610N21 Series Steam Sterilizer | FLE | Substantially Equivalent | |
| K201927 | Getinge GSS610N Series Steam Sterilizer | FLE | Substantially Equivalent | |
| K172159 | Getinge GSS67N Series Steam Sterilizer | FLE | Substantially Equivalent | |
| K070442 | POWERLED SURGICAL LIGHT SYSTEM | FSY | Substantially Equivalent | |
| K030071 | SERVO GUARD, MODEL 64 81 290 EH88E | CAH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013876692 | 3013876692 | GETINGE USA SALES, LLC | 45 Barbour Pond Dr, Wayne, NJ 07470 US | 2026 | No device listings on this registration |
| 8010652 | 1841 | MAQUET GMBH | KEHLER STRASSE 31, RASTATT Baden-Wurttemberg 76437 DE | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAHFilter, Bacterial, Breathing-Circuit
- HBMHeadrest, Neurosurgical
- IWYHolder, Head, Radiographic
- KIKHook, Bone
- FSYLight, Surgical, Ceiling Mounted
- FLESterilizer, Steam
- FPOStretcher, Wheeled
- LWGSurgical Table Cushion
- BWNTable And Attachments, Operating-Room
- FQOTable, Operating-Room, Ac-Powered
- FSETable, Operating-Room, Manual
- IXQTable, Radiographic, Stationary Top
- KXJTable, Radiologic
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
Recall records
Showing 25 of 199| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2420-2025 | Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions. | Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel. | Class II | Open, Classified | |
| Z-1074-2025 | Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia. | Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia. | Class I | Open, Classified | |
| Z-0463-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0462-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0461-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0460-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0459-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0458-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0457-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-0456-2025 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0 | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay | Class II | Open, Classified | |
| Z-2273-2024 | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. | Class II | Open, Classified | |
| Z-2272-2024 | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. | Class II | Open, Classified | |
| Z-2271-2024 | ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. | Class II | Open, Classified | |
| Z-1877-2024 | Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e. | Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia. | Class I | Open, Classified | |
| Z-1831-2024 | CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. | The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. | Class II | Open, Classified | |
| Z-1077-2024 | BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine. | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. | Class II | Open, Classified | |
| Z-1076-2024 | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine. | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection. | Class II | Open, Classified | |
| Z-0978-2024 | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. | Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis. | Class II | Open, Classified | |
| Z-0977-2024 | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. | Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis. | Class II | Open, Classified | |
| Z-1053-2024 | Bubble Sensor (REF: 70105.5720) | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device. | Class II | Open, Classified | |
| Z-0991-2024 | Flow-e Anesthesia System, model 6887900 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation. | Class II | Open, Classified | |
| Z-0990-2024 | Flow-c Anesthesia System, model 6887700 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation. | Class II | Open, Classified | |
| Z-0989-2024 | Flow-i C40 Anesthesia System, model 6677400 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation. | Class II | Open, Classified | |
| Z-0988-2024 | Flow-i C30 Anesthesia System, model 6677300 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation. | Class II | Open, Classified | |
| Z-0987-2024 | Flow-i C20 Anesthesia System, model 6677200 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain