IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 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.
Recall
- Recall Number
- Z-0645-2019
- Event Number
- 81574
- Firm
- Deerfield Imaging, Inc.
- FEI Number
- 3010326005
- Product Code
- FQO
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- November 6, 2018
- Terminated
- July 25, 2021
- Address
- 5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100
Description
IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 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.
Table may drift in the roll position while in use
The firm initiated the recall by letter on 11/06/2018. The letter explained the issue, requested the consignee follow the recommended daily test in all positions until the roll cylinders are exchanged.
Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
15 units