Z-2864-2018 Class II Terminated
FDA device recall Z-2864-2018 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 Upgrades (Stitching Patient Support) 712083
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: 437736/SN09000282 491574/SN12000099 488712 415314/SN0902058 445533/SN10000006 414930/SN08000055 SN13000238 SN13000214 504759/SN12000356 487719/SN11000538 504766/SN12000207 SN14000264 SN14000264 469223/SN10000643 493888/SN12000004 316236 306773 306776 334582 325938 SN08000301 396570/SN0802320 SN08000216