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…
Read the official notice →- Date
- 2022-04-27
- Country
- United States
- Brand
- Medtronic Xomed
- Product
- Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number…
- Classification
- Class II
- Units
- International distribution country of Japan.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medtronic Xomed recalls
- 2024-07-31
USMedtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM…
Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice →- 2024-01-17
- US
Medtronic Xomed, Inc. recalls NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d)…
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- 2022-09-07
- US
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2022-06-08
- US
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Software anomaly was identified.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide distribution in the states of TX, CO,…Official notice → - 2022-03-16
- US
Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube
There is potential for multiple issues due to a manufacturing nonconformity.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2021-10-27
- US
Medtronic Xomed, Inc. recalls Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
There was an increase in complaints related to tip breaks and wobble/vibration.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide, including PR. There was also…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-27
- US
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,…
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionWorldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 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
Huntleigh Healthcare Ltd. recalls HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Faceplate may become detached from the probe body.
FDA · DeviceHuntleigh Healthcare Ltd.US Nationwide distribution in the states of OK, CA, GA, MI, VA.Official notice → - US
Acumed LLC recalls 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture,…
FDA · DeviceAcumed LLCWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice → - US
Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
FDA · DeviceAbbottWorldwide distribution - US Nationwide - there was government distribution but…Official notice →