Z-0355-2022Class II

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

Name: Z-0355-2022 BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model...
Creator: Philips North America Llc
Published: 2021-11-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-11-12 / Open, Classified / root cause: design

FDA source

Philips North America Llc began a recall of BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075 on 2021-11-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0355-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-12
Posted: 2021-12-09
Recalling firm: Philips North America LLC
Product: BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Product code: OWB Interventional Fluoroscopic X-Ray System
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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 22 units US
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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0355-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0355-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0356-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-15	2021-12-09
Z-0357-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-15	2021-12-09

Product code OWB

K010435Class IIPhilips Bv Pulsera/enduraPhilips Medical Systems, Inc. / cleared 2001-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)