FDAFDA · Food and drugs·Recall number Z-2842-2018
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
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: SN17000395, SN17000372
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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