Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
This recall is currently active, issued September 19, 2023. It was issued by Ge Medical Systems Information Technologies Inc.
- Recall Initiated
- August 8, 2023
- Posted
- September 19, 2023
- Recall Number
- Z-2613-2023
- Quantity
- 81 amplifiers
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
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.
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 / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.