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
Read the official notice →- Date
- 2022-01-05
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-02-02
USSiemens Medical Solutions USA, Inc recalls Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be…
- 2022-01-26
- US
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…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI,…Official notice → - 2022-01-19
- US
Siemens Medical Solutions USA, Inc recalls SOMATOM Edge Plus-Computed tomography system Model 1026700
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- 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
- US
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient…
- 2021-11-24
- US
Siemens Medical Solutions USA, Inc recalls Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641…
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances,…
Other drugs & medical recalls in the United States
- 2022-01-12
- US
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2022-01-05
- US
AMO Manufacturing USA, LLC recalls iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive…
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations.…
FDA · DeviceAMO Manufacturing USA, LLCUS: CA, TX, FL, LA, MD, IA, MA, VA, SD, MN, MO, NC, TN, SC, WA, NV, OH, KY,…Official notice → - US
Karl Storz Endoscopy recalls Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA…
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and…
FDA · DeviceKarl Storz EndoscopyUS: AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of…
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice → - US
bioMerieux, Inc. recalls VIDAS RUB IgG (RBG), REF 30226
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
- US
Forbes Rehab Services Inc recalls Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components…
Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property