Signa Artist MRI systems recalled over unverified patient table caster lock maintenance
GE HealthCare is recalling 760 Signa Artist MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary actions; the notice reports an unconfirmed maintenance step rather than a device defect, with no injuries described.
Plain-English summary
GE HealthCare is recalling the Signa Artist nuclear magnetic resonance imaging system. The recall covers 760 units distributed worldwide, identified by GTIN numbers including 00840682123129, 00840682146104, 00195278117021, 00840682123457, 00195278126443 and 00195278210036.
GE HealthCare became aware that, for a group of MR systems that includes 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 and SIGNA Artist Evo, the planned maintenance steps that check the functionality of the caster locks on the MR patient table may not have been performed. The FDA classified the action as Class II.
Imaging sites operating an affected system should follow the manufacturer's instructions for having the caster lock check completed. GE HealthCare is contacting affected customers directly.
The recalled product
- Product
- GE Signa Artist, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Affected units
- 760
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- GTIN: 00840682123129
- 00840682146104
- 00195278117021
- 00840682123457
- 00195278126443
- 00195278210036
- Not available
- and Not applicable
- 2023
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 22 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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