Z-1217-2018 Class II Terminated
FDA device recall Z-1217-2018 was initiated by Deerfield Imaging, Inc. on February 23, 2018 and is designated Class II. Reason for recall: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked. The recall status is terminated (terminated August 27, 2019). Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- August 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Reason for Recall
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Distribution Pattern
US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Code Information
Serial numbers: 10006997, 10002692, 10006152, 10007192, 10006991, 10002220, 10003754, 10006997, 10004513, 10005201, 10006891, 10004463, 10005189, 10005190, 10004327, 10004997, 10006891