Medical diagnostic instrument recalled for electrical connector assembly defect
Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.
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 Class II FDA medical device recall involving a potential electrical safety hazard from an assembly defect. The incorrect power connector rating could cause device malfunction, but no injuries or illnesses have been reported, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the DxM 1040 MicroScan WalkAway Instrument (Model/Reference B1018-440) manufactured by Beckman Coulter Inc. A total of 40 systems were recalled because certain units were assembled with an incorrect AC power entry connector inlet rated at 1 ampere rather than the correct 10-ampere rating.
The defect in the power connector inlet could result in improper power delivery to the instrument and may cause device malfunction or electrical issues at the connection point. These recalled systems were distributed worldwide and throughout the United States, including 30 states and to 21 countries.
Facilities that have received affected units should discontinue use and contact Beckman Coulter Inc. immediately for replacement or repair instructions. Do not operate the instrument if it matches the affected serial numbers listed in the FDA recall notice (FDA Recall ID: Z-1085-2022, UDI-DI Code: 15099590690885).
The recalled product
- Product
- DxM 1040 MicroScan WalkAway Instrument REF B1018-440
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- electrical-hazard
- component-defect
Distribution
Distributed nationwide across the United States.
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