Reported Mar 16, 2022 · Ongoing
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird…
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 · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird
- chiller WITHOUT an extended drip trayModel
- Number722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039
- Lot codes and dates
- Allura Xper FD10 722003/722026 (US) S/N24 40 71
16219126628329431934740648582595996596798599012461353144419441949
- UDI(01)00884838054189(21)825 (01)00884838054189(21)967 (01)00884838054189(21)1246 (01)00884838054189(21)965 (01)00884838054189(21)959 (01)00884838054189(21)990 (01)00884838054189(21)985
- Allura Xper FD10/10 722005 S/N144
- US OUS37 52 74 79 80 108 279 417 459
- Allura Xper FD20 722006 S/NUS 44 72
23424626326832733342946947149851453555055458860471875476686111741274135514001783183118441878188619312018
- UDI(01)00884838054202(21)893
- OUS11 40 89
1021121251512443644084314845685805945976026406437048119409711262131214021405142414651481165816911794179618151852185918791891194819591974198519882141231125212554
- Allura Xper FD20 Biplane 722008 S/N
3382374 (US)
- OUS39 86 224 249 336 384 388 532
- Allura Xper FD10 722010 S/NOUS 163 340 1422 1429 1434
- Allura Xper FD20 722012 S/NOUS
39546392710131518265228542918
- Allura Xper FD20 OR Table 722015 S/N30 (OUS)
- Allura Xper FD10 722026 S/N OUS
315701748884888943948960971975978984989995
- Allura Xper FD10/10 722027 S/NOUS 268 278
- Allura Xper FD20/10 722029 S/NOUS 9
- Allura Xper FD10 722026 S/NUS 825 959 965 967 985 990 1246
- OUS11 40 89
1021121251512443644084314845685805945976026406437048119409711262131214021405142414651481165816911794179618151852185918791891194819591974198519882141231125212554
- Allura Xper FD10/10 266 722027 S/N266
- Allura Xper FD20 722028 S/N893
- UDI(01)00884838054202(21)893
- Allura Xper FD20/10 722029 S/N
9194
- US UDI(01)00884838054219(21)94
- OUSS/N:6
- Allura Xper FD10 722003/722026 (US) S/N24 40 71
- Amount recalled
- USA: 63 systems R.O.W.: 127 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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