Ion Beam Applications S.A. recalls Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical…
Read the official notice →- Date
- 2022-01-19
- Country
- United States
- Brand
- Ion Beam Applications
- Product
- Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- Classification
- Class II
- Units
- IN USA: VA, OK, NJ, TN OUS: Czech Republic.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ion Beam Applications recalls
- 2024-08-28
US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized…
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
FDA · DeviceIon Beam Applications S.A.IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy…Official notice →- 2024-06-12
US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized…
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the state of Virginia and the…Official notice →- 2024-05-01
US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
FDA · DeviceIon Beam Applications S.A.US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.Official notice →- 2023-11-22
US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient…
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of Arkansas, Florida,…Official notice →- 2022-06-08
US
Ion Beam Applications S.A. recalls Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose…
FDA · DeviceIon Beam Applications S.A.Worldwide distribution - US Nationwide distribution in the states of IL, VA,…Official notice →- 2022-03-16
US
Ion Beam Applications S.A. recalls ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and…
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually…
FDA · DeviceIon Beam Applications S.A.IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England,…Official notice →
Other drugs & medical recalls in the United States
- 2022-01-19
US
ROi CPS LLC recalls Regard, T AND A - Rogers, sterilized convenience kits
Kits lacks rubber latex warning label.
US
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia…
A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide distribution in the states of VA and…Official notice →US
Ki Mobility Llc recalls Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be…
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
US
Technomed Europe recalls Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
FDA · DeviceTechnomed EuropeUS Nationwide distribution in the states of California, Florida, and Ohio.Official notice →US
Akorn, Inc. recalls Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit…
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
US
Taro Pharmaceuticals U.S.A., Inc. recalls Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel…
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
FDA · DrugTaro Pharmaceuticals U.S.A., Inc.Two distributors in UT and LA who could have further distributed to the retail…Official notice →