TransMotion Medical Recalls Powered Stretcher Chairs Due to Involuntary Movement
TransMotion Medical Inc is recalling 1,127 powered stretcher chairs used in surgeries because the controllers may cause the chairs to move involuntarily.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a defect that causes involuntary movement during surgery, which poses a significant risk of injury to patients and staff, meeting the criteria for a Severe rating.
Plain-English summary
TransMotion Medical Inc is recalling 1,127 powered stretcher chairs used during facial and eye surgeries. The recall was initiated because the firm found that the stretcher chair controllers are moving the chairs involuntarily.
The affected units were distributed worldwide, including in the United States, Canada, Australia, and numerous other countries. The recall covers specific model numbers and serial numbers, which are listed in the official FDA recall notice.
Healthcare facilities and consumers should stop using the affected powered stretcher chairs immediately and contact TransMotion Medical Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- Powered stretcher chair used during facial and eye surgeries. One chair per package.
- Manufacturer
- TransMotion Medical Inc
- Affected units
- 1,127
Distribution
Distribution scope not specified by the agency.
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