Reported Feb 19, 2020 · Terminated
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20
- System codesAzurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure
- Lot codes and dates
- Serial NumbersAzurion: 213 713 711 716 710 709 439 8942 50
32063765368462110409008662127376288952811023697793146422912
56 897 896 940 574 70 141 865 1049 7173811031006296403267879428587251706611420877925
47 196 62 70 222 474 401 370 703 419395841084945838875853856354931909114
35 43 4060824710987973354838373602554711043323228359277974564416
37 293 74 341 346 66 772742254667508141016328329265679128644275783489
75 7 316 215 24 971 38 37 36 1133 76 524 406 949 1004 735 421 687593025575507561941129356234
617739586426434084075819076438263545459029179631058941083414103655956023623774574421741815210353131037215
79 35 638 410 134 583 824 254 52 190 285 242 127 219 876 76 290 475618157651122241052282444339138529405381162
637878127842213368742992281044315521323367260395126662258547509240
49386582533518238515985463983297288929768256186487105636274278112
61202893651500794296225528100139311635260200201541
51 1089 1008 271 491 492 60122128129457504548798647107236743510157293443439432926008252464585863281073648191652334173233289119456511951481191566238916301555556119211961190553934430399400364720
8337036910802831019104610817817752863983499417803341076616657309411
28 29 659 258 20 2910655491075984450786210192166144293578195142
39 179 767 300 182 701 482 772 2511839254413374311067223559326865512351109287286371
88 461 316 446 346 336 694 34 1056 45 41 42 44 43 141 432 391 764936493160819317107483548466511552252333810347782074521172969231377380379
- Allura25 28 39 38
- Serial NumbersAzurion: 213 713 711 716 710 709 439 89
- Amount recalled
- 443
Where it was sold
- Nationwide
Why it was recalled
Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips North America, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.