Medical analyzer instruments recalled for incorrect power connector rating
Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.
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: This is an FDA Class II recall of medical equipment with a potential electrical safety hazard from an undersized power connector. No illnesses or injuries have been reported, so the score is 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Beckman Coulter Inc. is recalling 49 DxM 1096 MicroScan WalkAway Instruments because some units may have been assembled with an incorrect AC power entry connector inlet. The connector is rated for 1 ampere of current instead of the correct 10 ampere rating.
This electrical safety defect could pose a risk during device operation. The affected instruments have been distributed worldwide, including throughout the United States and to multiple countries.
If you have one of the affected instruments, contact Beckman Coulter Inc. immediately. Do not use the device until it has been inspected and corrected by the manufacturer.
The recalled product
- Product
- DxM 1096 MicroScan WalkAway Instrument REF B1018-496
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 49
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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