Z-0646-2019 Class II Terminated
FDA device recall Z-0646-2019 was initiated by Deerfield Imaging, Inc. on November 6, 2018 and is designated Class II. Reason for recall: Table may drift in the roll position while in use The recall status is terminated (terminated July 25, 2021). Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- November 6, 2018
- Termination Date
- July 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Reason for Recall
Table may drift in the roll position while in use
Distribution Pattern
Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
Code Information
(a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10003830, 10002847, 10002796, 10003243, 10002654, 10003841, 10002607, 10007348, 10007424, 10005651, 10004250, 10004439, 10003241, 10006886, 10002848, 10006438, 10003007, 10004576, 10003245 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003244, 10002343