Philips 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.)
Read the official notice →- Date
- 2024-01-17
- Country
- United States
- Brand
- Philips
- Product
- (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
- Classification
- Class II
- Units
- Domestic distribution to the following states and territories: CA DE FL GA IL…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-01-24
US
Philips North America recalls (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model…
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
FDA · DevicePhilips North AmericaWorldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN,…Official notice →US
Philips North America Llc recalls Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Multiple software issues that affect device functionality.
FDA · DevicePhilips North America LlcDomestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium,…Official notice →US
Philips North America recalls Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG…
FDA · DevicePhilips North AmericaDomestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY…Official notice →- 2024-01-17
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 →- 2023-12-20
US
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…
FDA · DevicePhilips North America LlcDomestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE…Official notice →
Other drugs & medical recalls in the United States
- 2024-01-24
US
Pfizer Inc. recalls 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL…
Presence of Particulate Matter; identified as glass
US
Par Sterile Products LLC recalls Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton,…
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
US
Pharma Nobis LLC recalls Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400…
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- 2024-01-17
US
Ambu Inc. recalls Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the…
US
mo-Vis BVBA recalls Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering…
In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the…
US
Ortho-Clinical Diagnostics, Inc. recalls QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to…Official notice →