ProCuity Patient Beds Recalled for Missing Electrical Safety Tests
Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving a risk-of-harm condition (electrical shock and tissue burn) in a medical device with no reported illnesses or injuries. Risk-of-harm products where injury has not yet been reported typically rate as High (3).
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling the ProCuity bed series, model number 3009 (item number 3009PX-L-100). The beds are missing test values for electrical safety tests, which creates a potential risk of electrical shock or tissue burn to patients.
The affected beds have UDI-DI (GTIN) 07613327541168 with serial numbers 2111000766 and 2107000368. The recall affects beds distributed nationwide in the United States, including Puerto Rico, as well as internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.
Patients and healthcare facilities currently using these beds should stop using them immediately and contact Stryker Medical for instructions on replacement or repair. Healthcare providers should verify the serial numbers of their beds against the provided numbers to determine if their equipment is affected.
The recalled product
- Product
- ProCuity bed series, model number 3009, item number: 3009PX-L-100.
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Patient Beds
- Hazard
- electrical-shock
- burn-injury
- electrical-safety
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 (1)
- UDI-DI (GTIN): 07613327541168. Serial numbers: 2111000766 & 2107000368
Distribution
Distributed nationwide across the United States.
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