| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | November 12, 2021 |
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| Create Date | December 09, 2021 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0355-2022 |
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| Recall Event ID |
89129 |
| 510(K)Number | K010435 |
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| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system.
Model Number: 718075 |
|---|
| Code Information |
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
|
| FEI Number |
3016618143
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer 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 |
|---|
FDA Determined
Cause 2 | 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.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OWB
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