Siemens Medical Solutions USA, Inc recalls 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis…
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain…
Read the official notice →- Date
- 2022-01-26
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-03-23
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The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra,…Official notice →- 2022-02-09
- US
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Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-02-02
- US
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- 2022-01-19
- US
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- US
Siemens Medical Solutions USA, Inc recalls ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic…
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA,…Official notice → - 2021-12-01
- US
Siemens Medical Solutions USA, Inc recalls Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and…
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Other drugs & medical recalls in the United States
- 2022-01-26
- US
Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs.,…
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
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Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas…
FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of NY, PA, and WI.Official notice → - US
Konica Minolta Healthcare Americas, Inc. recalls ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on…
lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
- US
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Impacted lot may leak inside the ARIES instrument.
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