GE Medical Systems Information Technologies Inc: Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.

Recall number

Z-2613-2023

Recalling firm

GE Medical Systems Information Technologies Inc

Product

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

Status

Open, Classified

Initiated

2023-08-08

Posted

2023-09-19

Terminated

not on file

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.

Root cause

Component design/selection

Action

The recalling firm issued letters dated 8/8/2023 on the same day via FedEx. The letters explained the issue and listed actions to be taken by the customer/user. These included: (1) Ensure the facility has stable power. Lower voltage of the supplied power (e.g. 100V) causes more heat buildup and can cause the amplifier to fail; (2) Ensure the room temperature where the device is used is kept at < 30 degrees Celsius/86 degrees Fahrenheit. High temperatures (equal to or greater than 30 degrees Celsius/86 degrees Fahrenheit) can cause the amplifier to fail; (3) Ensure additional devices are available to monitor and/or stabilize the patient and/or complete the study (e.g., patient monitor, defibrillator, 3D Mapping system, etc.); and (4) Ensure that the hospital staff is familiar with utilizing the Direct Stimulator Connections on the CIM Block(s). This allows pacing from the stimulator when the amplifier has no power. The letter asks that all potential users in the consignee facility are made aware of this safety notification and recommended actions. GE Healthcare will correct all affected products and they will contact the consignee to plan for the hardware correction. An acknowledgment form was enclosed for completion and return no later than 30 days from receipt of the letter. The form is to acknowledge receipt and understanding of the letter and that the consignee has informed the appropriate staff and has taken appropriate actions. The form is to be completed by scanning or taking a photo of the completed form and emailing it back to the firm. A QR code is provided.

Quantity

81 amplifiers

Distribution

Distribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Canada, France, Germany, Greece, Ireland, Japan, Republic of Korea, and Romania.

Lot, serial or model codes

GTIN 00195278507044 (CardioLab) and 00195278507051 (ComboLab) Serial numbers for Amplifiers: SVS22330007SA, SVS22330008SA, SVS22330009SA, SVS22330010SA, SVS22330011SA, SVS22330012SA, SVS22330013SA, SVS22330014SA, SVS22330016SA, SVS22330017SA, SVS22330018SA, SVS22330019SA, SVS22330020SA, SVS22330021SA, SVS22330022SA, SVS22330023SA, SVS22330024SA, SVS22330025SA, SVS22330026SA, SVS22330028SA, SVS22330030SA, SVS22330031SA, SVS22330032SA, SVS22330033SA, SVS22330034SA, SVS22330035SA, SVS22440001SA, SVS22440002SA, SVS22440005SA, SVS22440008SA, SVS22440009SA, SVS22440010SA, SVS22440011SA, SVS22440012SA, SVS22440013SA, SVS22440016SA, SVS22490002SA, SVS22490003SA, SVS22490004SA, SVS22520006SA, SVS22520008SA, SVS22520009SA, SVS22520010SA, SVS22520011SA, SVS22520012SA, SVS22520013SA, SVS22520015SA, SVS23040001SA, SVS23040002SA, SVS23040003SA, SVS23040004SA, SVS23040005SA, SVS23040007SA, SVS23040008SA, SVS23040011SA, SVS23040012SA, SVS23040013SA, SVS23040014SA, SVS23040015SA, SVS23040016SA, SVS23040017SA, SVS23040018SA, SVS23040019SA, SVS23070002SA, SVS23070004SA, SVS23070005SA, SVS23070008SA, SVS23070009SA, SVS23070011SA, SVS23070012SA, SVS23100001SA, SVS23100002SA, SVS23100004SA, and SVS23100006SA. Serial numbers for FRUs: SVS22330015SA, SVS22440006SA, SVS22440007SA, SVS22440015SA, SVS22490001SA, SVS22520005SA, and SVS22520014SA.

510(k) numbers

["K213972"]

PMA numbers

not on file

Product code

DQK

Firm FEI

3012359877

Firm city

Wauwatosa

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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