Z-1264-2018 Class II Terminated
FDA device recall Z-1264-2018 was initiated by Deerfield Imaging, Inc. on February 23, 2018 and is designated Class II. Reason for recall: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. The recall status is terminated (terminated September 12, 2019). Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- September 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
Reason for Recall
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
Distribution Pattern
US, Canada, China, Australia, Sweden, Germany
Code Information
(a) 113821-000, Serial Numbers: 10006997, 10002220 (b) 113821-600, Serial Numbers: 10002692,10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005189, 10005190, 10006891, 10004997, 10004327 (d) 114148-600, Serial Numbers: 10005201, 10006891