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.
What this means for you
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
- 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
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