GE SIGNA Architect recall
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Why was GE SIGNA Architect 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 758 units
- Distribution
- Worldwide distribution.
- Recall date
- August 20, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)