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.
Enforcement
- Recall Number
- Z-0646-2019
- Event ID
- 81574
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Deerfield Imaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- November 6, 2018
- Classification Date
- December 20, 2018
- Termination Date
- July 25, 2021
- Address
- 5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100, United States
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.
Table may drift in the roll position while in use
(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
Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
27 units