Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2613-2023·Announced 2023-09-27

Prucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability

GE Medical Systems is recalling Prucka 3 Amplifiers and related field replaceable units used in CardioLab and ComboLab systems. A power supply diode may overheat and fail, causing the amplifier to stop working.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II device recall with no reported illnesses, injuries, or deaths. The hazard is equipment failure that renders the device inoperable rather than a direct safety threat to patients, consistent with voluntary precautionary recalls.

Plain-English summary

GE Medical Systems Information Technologies Inc is recalling Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX systems. A diode on the power supply can reach elevated temperatures and fail, causing the amplifier to power off and become inoperable.

The recall affects 81 amplifiers distributed across 17 U.S. states (CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, WI), government facilities, and international locations including Canada, France, Germany, Greece, Ireland, Japan, Republic of Korea, and Romania. Specific serial numbers have been identified for the affected amplifiers and field replaceable units.

Healthcare providers using affected systems should inspect their devices by serial number to determine if they are subject to this recall. GE Medical Systems recommends that affected customers contact the manufacturer for replacement units or repairs. No injuries or illnesses have been reported related to this issue.

The recalled product

Product: Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Manufacturer: GE Medical Systems Information Technologies Inc
Category: Medical Device — Cardiac Amplifier
Hazard: power-supply-failure
thermal-failure
Affected units: 81

Is your product affected?

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

Lot numbers (20)

SVS22330008SA
SVS22330009SA
SVS22330010SA
SVS22330011SA
SVS22330012SA
SVS22330013SA
SVS22330014SA
SVS22330016SA
SVS22330017SA
SVS22330018SA
SVS22330019SA
SVS22330020SA
SVS22330021SA
SVS22330022SA
SVS22330023SA
SVS22330024SA
SVS22330025SA
SVS22330026SA
SVS22330028SA
SVS22330030SA

Distribution

Distributed in 17 states:

Same manufacturer · GE Medical Systems Information Technologies Inc

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Same hazard · power supply failure