Optima MR450w 1.5T MRI recalled where caster lock maintenance may be unperformed
GE HealthCare is recalling 1,372 Optima MR450w 1.5T 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 describes an unconfirmed maintenance step rather than a device defect, and reports no injuries.
Plain-English summary
GE HealthCare is recalling the Optima MR450w 1.5T nuclear magnetic resonance imaging system. The recall covers 1,372 units distributed worldwide, identified by GTIN numbers including 00195278023643, 00195278117021, 00195278126443, 00195278210036, 00195278229519, 00840682115971 and 00840682118118.
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 Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Affected units
- 1,372
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 (14)
- 00195278023643
- 00195278117021
- 00195278126443
- 00195278210036
- 00195278229519
- 00840682115971
- 00840682118118
- 00840682118132
- 00840682123129
- 00840682123457
- 00840682146104
- Not applicable
- Not available
- 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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