Recall Z-2613-2023— GE Medical Systems Information Technologies Inc

Name: FDA recall Z-2613-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-08

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2023-08-08. It names one FDA 510(k) clearance: K213972. Product: Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.. Reason: 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..

Recalling firm: GE Medical Systems Information Technologies Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-08-08
Firm location: Wauwatosa, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K213972 — Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiXGe Healthcare Information Technologies, Inc.·cleared 2022-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.