FDA Medical devices recall ·
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall
- Recall number
- Z-2303-2025
- Date
- (initiated June 20, 2025)
- Company / brand
- GE Medical Systems, LLC
3200 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 758 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Why was it recalled?
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 00195278023643, 00195278117021, 00840682102728, 00840682103817, 00840682118118, 00840682122702, 00840682123129, 00840682123440, 00840682146197, 00840682147095, Not Applicable, Not available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2303-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.