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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost Upgrades (Stitching Patient Support) 712083

Z-2864-2018

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-2864-2018

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: 437736/SN09000282 491574/SN12000099 488712 415314/SN0902058 445533/SN10000006 414930/SN08000055 SN13000238 SN13000214 504759/SN12000356 487719/SN11000538 504766/SN12000207 SN14000264 SN14000264 469223/SN10000643 493888/SN12000004 316236 306773 306776 334582 325938 SN08000301 396570/SN0802320 SN08000216

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.