Z-2845-2018 Class II Terminated
FDA device recall Z-2845-2018 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 Release 3.1 (Stitching Patient Support) 712026
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: SN13000495 SN14000058 SN13000463 SN14000051 SN14000214 SN14000047 SN14000077 SN13000484 SN14000082 SN14000163 SN14000133 SN14000134 SN14000134 SN14000023 SN14000041
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2845-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026