DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
FDA Recall Z-2845-2018 · Posted 2018-08-17
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Recalling FirmPhilips Medical Systems Gmbh, DMC
Recall StatusTerminated
Product CodeMQB
Date Initiated2018-06-27
Date Terminated2024-04-30
Reason for Recall
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Firm Action
On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
Root Cause
Device Design
Distribution Pattern
US Nationwide; International to 66 countries
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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