Siemens Medical Solutions USA, Inc recalls MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515,…
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a…
Read the official notice →- Date
- 2025-10-08
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343,…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the countries of United Arab…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Siemens Medical Solutions recalls
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USSiemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ…
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There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AR, CA, NY and the…Official notice → - 2025-11-19
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Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X Upgrade. Model Number: 11689304.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting…
FDA · DeviceSiemens Medical Solutions USA, IncUS distribution to California. International distribution to Australia,…Official notice → - 2025-09-17
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Limited system movements after startup .
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A,…Official notice → - 2025-07-09
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Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
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- 2025-06-25
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Siemens Medical Solutions USA, Inc recalls UROSKOP Omnia Max. Model Number: 10762473
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Other drugs & medical recalls in the United States
- 2025-10-08
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Schiller, Ag recalls Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
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bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of…
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
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Medline Industries, LP recalls Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
The kits contain certain lots of cannula products where the catheter may not retain its shape.
- US
Howmedica Osteonics Corp. recalls 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of United Kingdom.Official notice → - US
Zap Surgical Systems recalls ZAP-X Radiosurgery System, Model: 300150
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Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use.…
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