Philips (1) Ingenia Ambition X (Product Number 781356) recall — FDA Z-0715-2024
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.)
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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.)
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…
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the…
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…
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products…
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the…
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…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of…
Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.
Undeclared Allergens - Milk and Soy
Undeclared Allergens - Milk and Soy
Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.
Undeclared Allergens - Milk and Soy
Undeclared Allergens - Milk and Soy
Undeclared Allergens - Milk and Soy
Undeclared Allergens - Milk and Soy
Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.
Undeclared Allergens - Milk and Soy
FDA lab analysis of product sampled revealed Chromium content was determined subpotent as 16 mcg/serving or 16% of declared.
Presence of Foreign Tablets/Capsules
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