LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Read the official notice →- Date
- 2025-03-05
- Country
- United States
- Brand
- Leica Biosystems Nussloch
- Product
- Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Leica Biosystems Nussloch recalls
- 2024-10-23
US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2;…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause…
- 2024-08-14
US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHUS Nationwide, including government distribution.Official notice →- 2024-06-12
US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice →- 2024-05-01
US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or…
Other drugs & medical recalls in the United States
- 2025-03-12
US
Safecor Health, LLC recalls Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster,…
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
US
- 2025-03-05
US
TERRAGENE S.A. recalls ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
US
GE Healthcare (China) Co., Ltd. recalls Brivo MR355, NMRI system
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to…
FDA · DeviceGE Healthcare (China) Co., Ltd.Domestic US distribution nationwide. International distribution worldwide.Official notice →US
Pentax of America Inc recalls Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic…
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and…
US
Scientia Vascular, Inc. recalls Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of…
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
FDA · DeviceScientia Vascular, Inc.U.S. Nationwide distribution in the state of DE.Official notice →