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Recall Observatory FDA recall evidence

Device product

EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

Z-2867-2018

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-2867-2018

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: 470350/SN10000103 482735/SN11000053 475222/SN11000013 486215/SN11000104 484559/SN11000063 77124552 499144/SN12000035 502428/SN12000048 505693/SN12000054

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.