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U.S. Department of Health and Human Services

Class 2 Device Recall Prucka 3 Amplifiers, Field Replaceable Units

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 Class 2 Device Recall Prucka 3 Amplifiers, Field Replaceable Unitssee related information
Date Initiated by FirmAugust 08, 2023
Date PostedSeptember 19, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2613-2023
Recall Event ID 92903
510(K)NumberK213972 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductPrucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Code Information 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.
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies Inc
9900 Innovation Dr
Wauwatosa WI 53226-4856
For Additional Information Contact
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionThe 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 Commerce81 amplifiers
DistributionDistribution 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQK
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