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.
Read the official notice →- Date
- 2025-03-12
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips IntelliSpace Cardiovascular software, Model 830089.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-05-14
USPhilips 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 →- 2025-04-30
- US
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.
- 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.
- 2025-02-26
- 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 → - 2025-02-12
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12 System Code: (1) 722063 (2) 722221
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice → - 2024-12-18
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura…
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide distribution. International distribution to Albania, Algeria,…Official notice →
Other drugs & medical recalls in the United States
- 2025-03-12
- US
MIM Software Inc recalls MIM software; System, Image Processing, Radiological
In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.
FDA · DeviceMIM Software IncWorldwide distribution - United States Nationwide and the countries of…Official notice → - US
Medtronic MiniMed, Inc. recalls MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- US
HUMAN MED AG recalls human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
- US
Medimaps Group recalls Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2,…
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
FDA · DeviceMedimaps GroupDomestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY,…Official notice → - US
Beckman Coulter, Inc. recalls Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal…
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased…
FDA · DeviceBeckman Coulter, Inc.Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR…Official notice →