Philips North America Llc recalls Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical…
Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain…
Read the official notice →- Date
- 2023-12-20
- Country
- United States
- Brand
- Philips
- Product
- Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical…
- Classification
- Class I
- Units
- Domestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 recalls
- 2024-01-17
USPhilips North America recalls (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
FDA · DevicePhilips North AmericaDomestic distribution to the following states and territories: CA DE FL GA IL…Official notice →- US
Philips North America recalls BrightView X, Gamma Camera, Product Code 882478
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients…
FDA · DevicePhilips North AmericaDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2023-12-27
- US
Philips North America Llc recalls The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional…
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
FDA · DevicePhilips North America LlcDomestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ,…Official notice → - 2023-11-29
- US
Philips North America Llc recalls SmartPath to dStream for 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
FDA · DevicePhilips North America LlcDomestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina,…Official notice → - 2023-11-22
- US
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This…
- US
Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Other drugs & medical recalls in the United States
- 2023-12-20
- US
Bebig Isotopentechnik Gmbh recalls SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
- US
BioReference Health, LLC recalls The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate…
Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.
- US
Spectranetics Corporation recalls Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW…
Incorrect product labeling. Exterior product box label does not match internal pouch label.
FDA · DeviceSpectranetics CorporationU.S Nationwide - Worldwide Distribution: US Distribution: AL, AR, AZ, CA, CO,…Official notice → - US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc.…
Failed Impurities/Degradation Specifications
- US
- US
Lupin Pharmaceuticals Inc. recalls Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202…
Failed Dissolution Specifications
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 3 wholesale/distributor accounts.Official notice →