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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Z-2845-2018

June 27, 2018

Class II

Product summary

Firm
Philips Medical Systems Gmbh, DMC
Event
Event 80577
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2845-2018

Official wording

Reason: 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.

Code information: Serial Numbers: SN13000495 SN14000058 SN13000463 SN14000051 SN14000214 SN14000047 SN14000077 SN13000484 SN14000082 SN14000163 SN14000133 SN14000134 SN14000134 SN14000023 SN14000041

Distribution pattern: US Nationwide; International to 66 countries

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.