FDA recall Z-2868-2018

Philips Medical Systems Gmbh, DMC · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide; International to 66 countries

Key facts

Status: Terminated
Initiation date: 2018-06-27
Report date: 2018-08-29
Termination date: 2024-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hamburg, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2868-2018