FDAFDA · Food and drugs·Recall number Z-2867-2018
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Published August 29, 2018 · Recall initiated: June 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems Gmbh, DMC
- Distributor
- US Nationwide; International to 66 countries
- Lot
- Serial Numbers: 470350/SN10000103 482735/SN11000053 475222/SN11000013 486215/SN11000104 484559/SN11000063 77124552 499144/SN12000035 502428/SN12000048 505693/SN12000054
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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