RecallRadar

FDA Device recall Z-0144-2015

IMRIS Operating Room table (ORT200 and ORT300)

On 2014-11-05 the FDA classified a Class II recall of IMRIS Operating Room table (ORT200 and ORT300) by Imris, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0144-2015
ClassificationClass II
Statusterminated
Initiated2014-10-01
Published2014-11-05
Last updated2026-09-13 11:53 UTC
CompanyImris
DistributionCA, FL, NC, NH, TN, UT

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.

Identifiers

code_info10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0144-2015%22

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