Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Read the official notice →- Date
- 2025-04-30
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile…
- Classification
- Class II
- Units
- US Nationwide distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Philips Medical Systems Nederland recalls
- 2025-06-18
US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7)…
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →- 2025-05-21
US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Master/Nova, Model Number: 781106;
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US: Nationwide Distribution International: Algeria, Andorra, Argentina,…Official notice →- 2025-05-14
US
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
FDA · DevicePhilips Medical Systems Nederland B.V.Domestic: Nationwide Distribution International: Australia, Austria, Belgium,…Official notice →- 2025-03-19
US
Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- 2025-03-12
US
Philips Medical Systems Nederland B.V. recalls Philips IntelliSpace Cardiovascular software, Model 830089.
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
FDA · DevicePhilips Medical Systems Nederland B.V.US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA,…Official notice →- 2025-02-26
US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Possibility of the patient falling from the table related to the mattress used on the patient table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldiwde distribution - US Nationwide and the countries of Afghanistan,…Official notice →
Other drugs & medical recalls in the United States
- 2025-04-30
US
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;…
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
FDA · DeviceMedtronic Xomed, Inc.Worldwide - US Nationwide distribution including in the states of MD, MN, PA,…Official notice →US
Maquet Cardiovascular, LLC recalls The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length…
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Mexico, United…Official notice →US
Conavi Medical Inc. recalls Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common…
Due to manufacturing issues there is a potential for the catheter sheath to detach.
FDA · DeviceConavi Medical Inc.US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries…Official notice →US
Philips North America Llc recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
US
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L.,…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
US