Recall Z-0144-2015— IMRIS Inc
Class II · Terminated
Class II FDA medical device recall by IMRIS Inc, initiated 2014-10-01, terminated 2015-02-20. FDA's recall record names no specific 510(k) clearance for this event. Product: IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.. Reason: One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility..
- Recalling firm
- IMRIS Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-01
- Terminated
- 2015-02-20
- Firm location
- Hopkins, MN, United States
Product description
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Reason for recall
One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.