Device product

EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

Z-2868-2018

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-2868-2018

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: SN17000027 SN16000011 SN16000014 SN16000036 SN16000015 SN15000050 476034/SN12000027 476338/SN12000026 SN17000022 SN15000029 SN16000017 SN16000009 SN13000078 SN16000048 SN16000004 SN13000029 SN14000068 511923/SN12000044 514827/SN12000098 514827/SN12000098 SN14000044 ***Updated 5/6/21*** SN15000055

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.