GE Cabinet X-ray systems

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.
  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:
GE Inspection Technologies, LP
Reason for Recall:
GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GE Cabinet X-ray systems

Product Codes/Lot Numbers:

XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.

Distribution:

Distributed in: US, MI, PA, NH, CA, OR, WA, NC, IN, SC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0426-2015

Related Recalls

Class I - Dangerous

It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on.

Sep 29, 2020 Diagnostic Equipment View Details →

GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.

Jun 28, 2017 Other Medical Devices View Details →

Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.

Mar 2, 2016 Other Medical Devices View Details →