Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect

Plain-English summary

Radiometer Medical ApS is recalling two units of the ABL800 FLEX blood gas analyzer (model numbers 393-800 and 393-801) in the United States. The affected units were distributed in the state of California and have serial numbers 902-754R2692N002 and 902-754R2692N001.

The recall was initiated after an internal investigation determined that an incorrect component was used within the power supply of these devices. This defect may cause a short circuit within the power supply, resulting in a delay in patient treatment. The source text notes that such delays could result in a range of risks, including cyanosis, low blood pressure, cardiac arrhythmias, and severe impairment of cardiac function.

Healthcare facilities and users should identify the affected units by checking the serial numbers and model numbers listed above. Users should contact Radiometer Medical ApS for instructions on how to proceed with the recall and replacement or repair of the devices.

The recalled product

Product

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

Manufacturer

Radiometer Medical ApS

Category

Medical Device — Blood Gas Analyzer

Hazard

• electrical-short-circuit
• treatment-delay
• cardiac-arrhythmia

Affected units

2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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