Z-0764-2024Class II
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL...
Maquet Cardiovascular Us Sales, LLC / initiated 2023-11-08 / Open, Classified / root cause: manufacturing process
Getinge Usa Sales Inc began a recall of Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL... on . FDA classified it as Class II and gives the reason as "A potential for a light system to fall in the operating room". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0764-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Maquet Cardiovascular Us Sales, LLC
- Product
- Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567502961C, AXL+5001 SF - ARD567502861C, AXL+5301 DF - ARD567502971C, AXL+5501 DF - ARD567502960C, AXL+5501 SF - ARD567502860C, AXL+5531 DF - ARD567502930C, AXL50 RLC - ARDRLC309000C, AXL50 RLC - ARDRLC309006C, AXL5003 - ARD567505968C, AXL5003 US - ARD567505969C
- Product code
- FSY Light, Surgical, Ceiling Mounted
- Reason for recall
- A potential for a light system to fall in the operating room.
- Root cause tag
- manufacturing process
- FDA root cause
- Equipment maintenance
- Action
- An URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below. Please distribute this notice and forward the link below to access manuals to anyone within your organization who may need to use the manuals, and especially to your service or service provider who performs your maintenance. Light system fixing and other replacements: Regarding: - the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws - the brake screws - the safety segments - the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued. The instruction is available on a dedicated space on the web portal https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/, and provided upon request by emailing [email protected] Should you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (866) 350-0897. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Maquet SAS / Getinge: As the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin
- Quantity in commerce
- 236793 units in total
- Distribution
- US Nationwide. Global Distribution.
- Product codes and lots
- All systems affected
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0757-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0758-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0759-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0760-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0761-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0762-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0763-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0764-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0765-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0766-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0767-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0768-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0769-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0770-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0771-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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