IMRIS Operating Room table recall
IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a…
Why was IMRIS Operating Room table recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
- Product
- IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a…
- Recalling firm
- IMRIS Inc
- Quantity
- 14
- Distribution
- Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
- Recall date
- November 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)