GE Medical Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-2342-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

GE HealthCare OEC 9900 Elite C-arm Systems.

Product Classification:

Class II

Date Initiated: July 2, 2025

Date Posted: September 3, 2025

Recall Number: Z-2342-2025

Event ID: 97454

Reason for Recall:

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

Status: Ongoing

Product Quantity:

Code Information:

GTIN: 00840682114349

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

FDA Mandated