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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Z-2862-2018

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-2862-2018

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: SN14000256 SN14000250 SN15000024 SN14000170 SN14000052 SN14000224 SN15000039 SN14000144 SN14000253 SN14000239 SN14000186 SN14000075 SN14000193 SN14000254 SN15000001 SN14000089 SN14000223 SN14000267 SN14000238 SN14000164 SN14000165 SN14000200 SN14000005 SN14000040 SN15000015 SN15000029 SN14000120

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.