St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER3700 programmer Model MER3400 software
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices,…
Read the official notice →- Date
- 2022-04-27
- Country
- United States
- Brand
- St. Jude Medical, Cardiac Rhythm Management Division
- Product
- Merlin 2 PCS MER3700 programmer Model MER3400 software
- Classification
- Class II
- Units
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 St. Jude Medical, Cardiac Rhythm Management Division recalls
- 2022-08-10
USSt. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER37000 programmer Model MER3400 software
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice →- US
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS 3650 programmer Model 3330 software
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - 2022-04-27
- US
St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the…
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionWorldwide distribution - US Nationwide distribution in the states of FL, KY…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-27
- US
GE Healthcare, LLC recalls GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T,…
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution: US (nationwide), including Puerto Rico and the U.S.…Official notice → - US
DNA Genotek Inc. recalls ORAcollect RNA: ORE-100
Evaporation of stabilizing liquid reducing shelf life.
FDA · DeviceDNA Genotek Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis zee floor MN, Model Number 10094142
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a…
- US
SIGHT DIAGNOSTICS LTD recalls The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image…
In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628…
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows.…
- US
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number…
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between…