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Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable… recallZ-2613-2023 · GE Medical Systems Information Technologies Inc · initiated Aug 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems Information Technologies Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2613-2023
Status
Open, Classified
Initiated by the company
Aug 8, 2023
Posted by the FDA
Sep 19, 2023
Recalling firm
GE Medical Systems Information Technologies Inc
Quantity
81 amplifiers
Product code
DQK
FDA submissions
K213972
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 description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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