MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating
Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.
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 a risk-of-harm product with a potential electrical and fire hazard, but no illnesses or injuries have been reported in the source. The hazard stems from an undersized connector that could overheat under the instrument's normal operating load.
Plain-English summary
Beckman Coulter Inc. has recalled three MicroScan WalkAway-40 plus reconditioned medical instruments (catalog number B1018-340R) due to an assembly defect in the AC power entry connector.
The instruments were assembled with an AC power entry connector inlet rated for 1 ampere instead of the correct 10 ampere rating. This mismatch between the connector's design rating and the instrument's power requirements creates a potential electrical and fire hazard.
The recalled instruments were distributed worldwide, with U.S. distribution across 31 states and territories, and international distribution across 20 countries including 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.
The recalled product
- Product
- MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 6 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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