Reported Nov 5, 2014 · Terminated

IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures…

IMRIS Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: IMRIS Inc · 5101 Shady Oak Rd S · Hopkins, MN · 55343-4100

Is this the product you have?

  • IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Lot codes and dates
    • 10006991
    • 10006997
    • 10005201
    • 10006891
    • 10004513
    • 10002692
    • 10004513
    • 10002220
    • 10007376
    • 10007377
    • 10002996
    • and 10002255
Amount recalled
14

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 20, 2015 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.