Z-2850-2018 Class II Terminated
FDA device recall Z-2850-2018 was initiated by Philips Medical Systems Gmbh, DMC on Jun 27, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 30, 2024).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jun 27, 2018
- Termination Date
- Apr 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
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 Pattern
US Nationwide; International to 66 countries
Code Information
Serial Numbers: SN17000283 SN15000078 SN15000115 SN17000326 SN15000114 SN17000171 SN17000058 SN17000190 SN15000016 SN15000316 SN17000027 SN14000047 SN17000024 SN15000015 SN17000342 SN14000108
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2850-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026