Z-0760-2024Class II
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL...
Maquet Cardiovascular Us Sales, LLC / initiated 2023-11-08 / Open, Classified / root cause: manufacturing process
Getinge Usa Sales Inc began a recall of Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A... 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-0760-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Maquet Cardiovascular Us Sales, LLC
- Product
- Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60SF - ARDROL309036A, ROL VST60SF B - ARDROL309038A, ROL VCSII40SF - ARDROL309039A, ROL VCSII40SF - ARDROL309040A, ROL VCSII60SF - ARDROL309041A, ROL VCSII60SF - ARDROL309042A, ROL PWDII50SF - ARDROL309043A, ROL PWDII50SF - ARDROL309044A, ROL PWDII70SF - ARDROL309045A, ROL PWDII70SF - ARDROL309046A, ROL PWDII50SF - ARDROL309047A, ROL PWDII50SF - ARDROL309048A, ROL PWDII70SF - ARDROL309049A, ROL PWDII70SF - ARDROL309050A, ROL VSTII40SF - ARDROL309051A, ROL VSTII60SF - ARDROL309052A, ROL VSTII40SF - ARDROL309053A, ROL VSTII60SF - ARDROL309054A
- Product code
- FTD Lamp, Surgical
- 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 UDI-DI: 3700712411978 3700712411985 3700712412050 3700712412067 3700712412036 3700712412043 3700712412111 3700712412128 3700712417062 3700712417079 3700712417086 3700712417093 3700712419240 3700712417109 3700712417116 3700712419257 3700712422707 3700712422714 3700712422721 3700712422738 3700712422745 3700712422752 3700712422769 3700712422776 3700712422783 3700712422790 3700712422806 3700712422813 3700712422820 3700712422837 3700712422844 3700712422851
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.