Brainlab AG recalls Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Read the official notice →- Date
- 2025-03-26
- Country
- United States
- Brand
- Brainlab
- Product
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Brainlab recalls
- 2023-04-05
USBrainlab AG recalls Cirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device
- 2023-03-22
- US
Brainlab AG recalls Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
FDA · DeviceBrainlab AGUS Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN,…Official notice → - 2022-03-16
- US
Brainlab AG recalls ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST;…
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
FDA · DeviceBrainlab AGDistribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY,…Official notice →
Other drugs & medical recalls in the United States
- 2025-03-26
- US
B Braun Medical Inc recalls Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Increased risk for valve housing detachment causing leakage.
FDA · DeviceB Braun Medical IncDomestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA,…Official notice → - US
Remel, Inc recalls Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ…
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
FDA · DeviceRemel, IncDomestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide - US Nationwide and the country of Canada.Official notice → - US
Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product is mislabeled with the incorrect fill volume.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.Official notice → - US
Immuno-Mycologics, Inc recalls Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for…
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
FDA · DeviceImmuno-Mycologics, IncWorldwide - US Nationwide distribution in the states of CA and OK and the…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.