Stryker Power-LOAD Ambulance Cot Fastener System Recall for Load Switch Defect
Stryker is recalling 24 Model 6390 Power-LOAD systems because a load switch slide may not meet specifications, negatively impacting the lifting ability of the arms.
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: The recall is classified as FDA Class II, and the defect negatively impacts the lifting ability of the ambulance cot arms, presenting a risk of harm to patients or operators, although no specific injuries are reported in the source text.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 24 units of the Model 6390 Power-LOAD power-loading cot fastener system. These devices are designed to lift, lower, or steer ambulance cots into and out of the ambulance. The recall affects units built between September 12, 2012, and September 27, 2012.
The recall is being issued because the affected systems may have been built with a load switch slide that does not meet specifications. This defect can negatively impact the lifting ability of the arms. The devices were distributed nationwide in the United States, including in Pennsylvania, New Mexico, Michigan, Iowa, California, Colorado, Washington, Virginia, Illinois, Wisconsin, New York, Wyoming, Missouri, Texas, and Connecticut.
Users of these devices should stop using the affected units and contact Stryker for instructions on how to resolve the issue. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 24
Distribution
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