PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers…
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied…
Read the official notice →- Date
- 2024-09-11
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
- Classification
- Class II
- Units
- Worldwide - 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-12-18
USPHILIPS 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 →- 2024-11-20
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 50, Model Number: 718096
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - 2024-09-25
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia…Official notice → - 2024-08-28
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010,…
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of IL and OR. The…Official notice → - 2024-08-14
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - 2024-06-05
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of…
Potential for pressure wave data synchronization from two devices may not be correct.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide in the states of CA, IN, OR and the…Official notice →
Other drugs & medical recalls in the United States
- 2024-09-18
- US
PREQUEL SKIN recalls BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8…
Microbial contamination of non-sterile Products -
- 2024-09-11
- US
Beckman Coulter Biomedical GmbH recalls PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the…
FDA · DeviceBeckman Coulter Biomedical GmbHWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Mindray DS USA, Inc. dba Mindray North America recalls Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an…
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System…
FDA · DeviceMindray DS USA, Inc. dba Mindray North AmericaUS Distribution to states of: California, Georgia, Kentucky, Mississippi, New…Official notice → - US
CareFusion 303, Inc. recalls BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.Official notice → - US
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA · DeviceW L Gore & Associates, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →