🔍 RecallPedia

IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600

Class I - Dangerous
🏥 Medical Devices Recalled: February 23, 2018 Deerfield Imaging Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    (a) 108000-000, Serial Numbers: 10000239, 10000983, 10000233 (b) 108000-600, Serial Numbers: 10001306 (c) 109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d) 109682-600, Serial Numbers: 10001119, 10003623, 05-002, 10003634, 10001188, 10003638, 10001192
  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:
Deerfield Imaging, Inc.
Reason for Recall:
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600

Product Codes/Lot Numbers:

(a) 108000-000, Serial Numbers: 10000239, 10000983, 10000233 (b) 108000-600, Serial Numbers: 10001306 (c) 109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d) 109682-600, Serial Numbers: 10001119, 10003623, 05-002, 10003634, 10001188, 10003638, 10001192

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1265-2018

Related Recalls

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

Deerfield Imaging

Class I - Dangerous

Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.

Feb 17, 2022 Other Medical Devices Nationwide View Details →