Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.
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 an FDA Class II medical device recall involving a potential electrical safety hazard from an underated power connector. Although no injuries have been reported, an undersized electrical connector in a medical device represents a risk-of-harm product that could fail during normal operation.
Plain-English summary
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments (Catalog Number B1018-284) due to an AC power connector assembly defect.
The affected instruments may have been assembled with an AC power entry connector inlet rated at 1 ampere instead of the correct 10 ampere rating. An underated connector could fail or overheat during normal operation, creating a potential electrical hazard.
The recall affects instruments with serial numbers 39610007 through 39610013, distributed worldwide including throughout the United States and to Belgium, Brazil, Colombia, Germany, Hong Kong, Indonesia, Italy, Japan, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, Vietnam, and Yemen.
If you own an affected instrument, verify your serial number and contact Beckman Coulter Inc. immediately for instructions regarding replacement or corrective action.
The recalled product
- Product
- MicroScan WalkAway-96 plus Instrument REF B1018-284
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- electrical-safety
- equipment-failure
Distribution
Distributed nationwide across the United States.
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