IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
IMRIS Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Product Codes/Lot Numbers:

10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.

Distribution:

Distributed in: CA, FL, NH, NC, TN, UT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0144-2015