Reported Sep 27, 2023 · Ongoing
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and…
GE Medical Systems Information Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems Information Technologies Inc · 9900 Innovation Dr · Wauwatosa, WI · 53226-4856
Is this the product you have?
Prucka 3 AmplifiersModel P1801PAand Field Replaceable Units (FRUs)Model 5875569used with CardioLab AltiX and ComboLab AltiX
- Lot codes and dates
- GTIN 00195278507044 (CardioLab) and 00195278507051 (ComboLab)
- Serial numbers for Amplifiers
74 of 74 codes
SVS22330007SASVS22330008SASVS22330009SASVS22330010SASVS22330011SASVS22330012SASVS22330013SASVS22330014SASVS22330016SASVS22330017SASVS22330018SASVS22330019SASVS22330020SASVS22330021SASVS22330022SASVS22330023SASVS22330024SASVS22330025SASVS22330026SASVS22330028SASVS22330030SASVS22330031SASVS22330032SASVS22330033SASVS22330034SASVS22330035SASVS22440001SASVS22440002SASVS22440005SASVS22440008SASVS22440009SASVS22440010SASVS22440011SASVS22440012SASVS22440013SASVS22440016SASVS22490002SASVS22490003SASVS22490004SASVS22520006SASVS22520008SASVS22520009SASVS22520010SASVS22520011SASVS22520012SASVS22520013SASVS22520015SASVS23040001SASVS23040002SASVS23040003SASVS23040004SASVS23040005SASVS23040007SASVS23040008SASVS23040011SASVS23040012SASVS23040013SASVS23040014SASVS23040015SASVS23040016SA
- Serial numbers for FRUs
SVS22330015SASVS22440006SASVS22440007SASVS22440015SASVS22490001SASVS22520005SAand SVS22520014SA
- Amount recalled
- 81 amplifiers
Where it was sold
Why it was recalled
A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
This product could cause temporary or reversible health problems — stop using it.
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