FDA Medical Device Recalls (openFDA)
IMRIS Inc: IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
- Recall number
- Z-0144-2015
- Recalling firm
- IMRIS Inc
- Product
- IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
- Status
- Terminated
- Initiated
- 2014-10-01
- Posted
- 2014-10-28
- Terminated
- 2015-02-20
- 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.
- Root cause
- Use error
- Action
- Consignees were sent on 10/01/2014 an IMRIS "Urgent Field Safety Notice" letter dated September 25, 2014. The letter described the problem and the product involved in the recall. The letter informed consignees that the pins will be replaced with pins made of non-ferrous material. Customers are to ensure that users are aware of the changes and the existing procedure for table alignment and managing ferrous content in the magnet room. Contact customer support at 1-866-475-0525 for questions.
- 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.
- Lot, serial or model codes
- 10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQO
- Firm FEI
- 3010326005
- Firm city
- Hopkins
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28