ProCuity Patient Beds Missing Electrical Safety Tests: Burn and Shock Risk
Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.
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: FDA Class II recall for a risk-of-harm product (electrical shock and tissue burn hazard). No illnesses or injuries are reported in the source text, so the recall meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling certain ProCuity patient beds (model 3009) due to missing electrical safety test values. These test values are required to ensure the beds meet electrical safety standards.
The missing test documentation presents a risk of electrical shock or tissue burn to patients and healthcare workers who may contact the bed during operation or maintenance.
The affected beds were distributed nationwide in the United States and to healthcare facilities in Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Specific serial numbers have been identified for the affected units.
Healthcare facilities and users should verify their device serial numbers against the FDA recall notice and contact Stryker for guidance on inspection, testing, or replacement procedures.
The recalled product
- Product
- ProCuity bed series, model number 3009, item number: 300900000000,
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- electrical-shock
- tissue-burn
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 (20)
- UDI-DI (GTIN): 07613327512656. Serial numbers: 2207000698
- 2207000676
- 2207000619
- 2206001100
- 2206001090
- 2206001089
- 2206001086
- 2206001084
- 2208001745
- 2208001734
- 2208001725
- 2208001724
- 2208000397
- 2208000394
- 2208000032
- 2209002157
- 2209002158
- 2209002165
- 2210000711
- 2210000721
Distribution
Distributed nationwide across the United States.
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