—#190585

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010435
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Philips issued an Urgent Medical Device Correction letter in the USA on 11/12/21 via Certified mailing United States Postal Service. Recalling outside the US is done through the local Philips organizations in the respective countries Letter states reason for recall, health risk and action to take: Pay attention to the Heat Indication Level Icons shown in the Viewing Station to know the temperature of the X-Ray Tank. o Follow the instructions provided in Annex I of this letter for a safe use of the system. o Circulate this notice to all users of this device so that they are aware of the issue. o Place this Field safety Notice with the documentation of the of your system o Transfer this Field Safety notice within your organization or to any organization, if the affected devices have been transferred. o Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this Urgent Field Safety Notice. 5. Actions planned by Philips IGT Systems to correct the problem Philips is informing customers through this Urgent Field Safety Notice and providing the Addendum to the Instructions For Use of the BV Endura Release 2.3, BV Pulsera Release 2.3 and Veradius Unity Release 2.1 systems.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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 Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives Mali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, Zimbabwe.

Timeline

Recall initiated: 2021-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.