Philips North America Llc: BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

Is my product affected?

BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

• UPC 00884838055490

Check against the official notice below — it lists the full affected range.

What happened

Philips North America is recalling the BV Endura with Software Release 2.3, a mobile diagnostic X-ray system used for image acquisition and viewing. The recall affects 22 units in the United States and was distributed worldwide. The problem is that the Instructions for Use do not specify the maximum surface temperature of the X-ray tank (which houses the X-ray tube, beam filter, and cooling oil) or the image intensifier/detector, creating a risk of burns to users or patients who may come into contact with these hot components.

The recall involves specific serial numbers listed in the recall documentation. According to the source record provided, no remedy is specified for this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

Details from the source

Reason for recall: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French G Quantity: 22 units US Lot/code info: Serial Number: 173 105 5301 4950 5360 4651 4891 873 1633 160 543 562 204 5090 5091 5092 4840 5073 125 383 384 5121 UDI: (01)00884838055490(21)173 (01)00884838055490(21)105 (01)00884838055490(21)5301 (01)00884838055490(21)4950 (01)00884838055490(21)5360 (01)00884838055490(21)4651 (01)00884838055490(21)4891 (01)00884838055490(21)873 (01)00884838055490(21)1633 (01)00884838055490(21)160 (01)00884838055490(21)543 (01)00884838055490(21)562 (01)00884838055490(21)204 (01)00884838055490(21)5090 (01)00884838055490(21)5091 (01)00884838055490(21)5092 (01)00884838055490(21)4840 (01)00884838055490(21)5073 (01)00884838055490(21)125 (01)00884838055490(21)383 (01)00884838055490(21)384 (01)00884838055490(21)5121

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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