Z-2842-2018 Class II Terminated
FDA device recall Z-2842-2018 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). Affected quantity: 2 units.
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
- 2 units
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: SN17000395, SN17000372