DigitalDiagnost 4 — Class II medical device recall Z-2854-2018
Terminated recall by Philips Medical Systems Gmbh, DMC, reported 2018-08-29, distributed nationwide. The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or s
| Recall number | Z-2854-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Gmbh, DMC, Hamburg, Germany |
| Recall initiated | 2018-06-27 |
| Classified | 2018-08-17 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Serial numbers | 550162, SN15000173, SN15000174, SN15000225, SN15000283, SN15000288, SN15000304, SN15000350, SN15000379, SN16000008, SN16000023, SN16000092, SN16000104, SN16000124, SN16000197, SN16000234, SN16000283 |
Product
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.