Z-2613-2023Class II

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

Name: Z-2613-2023 Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab...
Creator: GE Medical Systems Information Technologies Inc
Published: 2023-08-08
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2023-08-08 / Open, Classified / root cause: design

FDA source

GE Medical Systems Information Technologies Inc began a recall of Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX on 2023-08-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2613-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-08
Posted: 2023-09-19
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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2613-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2613-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19

Product code DQK

K213972Class IIMac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiXGe Healthcare Information Technologies, Inc. / cleared 2022-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)