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Recall Observatory FDA recall evidence

Device 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.

Z-0566-2013

October 11, 2012

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 63604
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-0566-2013

Official wording

Reason: Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.

Code information: Item 6390000000 Serial Numbers: 120940217 120940257 120940259 120940260 120940261 120940275 120940276 120940277 120940290 120940291 120940292 120940293 120940294 120940431 120940435 120940436 120940437 120940448 120940449 120940454 120940458 120940459 120940203 120940258

Distribution pattern: USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    does not meet specifications