Z-2844-2018 Class II Terminated
FDA device recall Z-2844-2018 was initiated by Philips Medical Systems Gmbh, DMC on June 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 April 30, 2024).
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- June 27, 2018
- Termination Date
- April 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
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: 510694/SN12000240 510890/SN12000259 511451/SN13000066 510334/SN12000218 511346/SN13000008 511214/SN12000353 12000161 510089/SN12000293