IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
FDA Recall Z-0144-2015 · Posted 2014-10-28
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Recalling FirmIMRIS Inc
Recall StatusTerminated
Product CodeFQO
Date Initiated2014-10-01
Date Terminated2015-02-20
Product Quantity14
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.
Firm 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.
Root Cause
Use error
Distribution Pattern
Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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