GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab…
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
Read the official notice →- Date
- 2024-07-10
- Country
- United States
- Brand
- GE Medical Systems Information Technologies
- Product
- Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AK, AZ, CA, CO, FL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More GE Medical Systems Information Technologies recalls
- 2026-08-12
USGE Medical Systems Information Technologies Inc recalls GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a…
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide distribution - US Nationwide and the countries of Belgium, Hong…Official notice →- 2026-06-10
- US
GE Medical Systems Information Technologies Inc recalls CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal…
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2026-06-03
- US
GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA;…
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF…
- 2025-06-18
- US
GE Medical Systems Information Technologies Inc recalls MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer…
The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide - US Nationwide distribution.Official notice → - 2024-06-12
- US
GE Medical Systems Information Technologies Inc recalls GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB…
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
FDA · DeviceGE Medical Systems Information Technologies IncUS Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL,…Official notice → - 2023-09-27
- US
GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX…
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 · DeviceGE Medical Systems Information Technologies IncDistribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-10
- US
Zyno Medical LLC recalls Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having…
- US
CareFusion 303, Inc. recalls BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT…Official notice → - US
Stryker Corporation recalls The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood…
Expired Products distributed to customers
FDA · DeviceStryker CorporationUS Nationwide distribution in the states of Arkansas, California, Colorado,…Official notice → - US
Nalu Medical, Inc. recalls Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US…
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be…
FDA · DeviceNalu Medical, Inc.US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI…
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS,…Official notice → - US
Megadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return…
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
FDA · DeviceMegadyne Medical Products, Inc.Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN,…Official notice →