Medical cot may experience unintended motion due to cable damage
Stryker's Power-PRO 2 surgical cot may lower unexpectedly due to damaged cables, risking soft tissue injuries to patients. The recall affects 465 units distributed in the US and internationally.
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 3/5 (High).
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 recall involves a mechanical failure (damaged cables) that creates a real risk of soft tissue injury to patients, though no injuries have been reported. This fits the 'risk-of-harm product where injury has not yet been reported' criterion for a High severity rating.
Plain-English summary
Stryker Medical Division of Stryker Corporation has recalled the Power-PRO 2 surgical cot, Model No. 6507. The device may experience unintended motion due to damaged cables.
Damaged cables in affected units can cause the cot to lower faster than intended. This creates a risk of soft tissue injury to patients, such as scrapes or bruising.
The recall affects 465 units, including 403 in the United States and 62 units distributed internationally to Australia, Canada, the Netherlands, and the United Kingdom. The FDA has classified this as a Class II medical device recall.
The recalled product
- Product
- Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
- Manufacturer
- Stryker Medical Division of Stryker Corporation
Distribution
Distributed nationwide across the United States.
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