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Allura Xper FD recallZ-0724-2022 · Philips North America Llc · initiated Nov 24, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

Philips Issued Medical Device Correction letter dated 11/24/21 to U.S.A, Customers via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and action to take: Philips will inspect the affected systems for leaks and repair as required. In addition, Philips will install an extended drip tray to prevent damage from any future leaks. This service will be provided free of charge for affected systems. A Philips service representative will contact customers with affected devices to arrange for the service. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 (reference FCC 72200484).

Recall details

Recall number
Z-0724-2022
Status
Open, Classified
Initiated by the company
Nov 24, 2021
Recalling firm
Philips North America Llc
Quantity
USA: 63 systems R.O.W.: 127 systems
Product code
OWB
FDA submissions
K141979, K161563
Distribution
US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey United Kingdom Virgin Islands (U.S.)

Product description

Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Allura Xper FD10 722003/722026  (US) S/N:  24 40 71 162 191 266 283 294 319 347 406 485 825 959 965 967 985 990 1246 1353 1444 1944 1949 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/N: 144 US OUS: 37 52 74 79 80 108 279 417 459  Allura Xper FD20 722006 S/N: US 44 72 234 246 263 268 327 333 429 469 471 498 514 535 550 554 588 604 718 754 766 861 1174 1274 1355 1400 1783 1831 1844 1878 1886 1931 2018 UDI: (01)00884838054202(21)893  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554   Allura Xper FD20 Biplane 722008 S/N: 33, 82, 374 (US) OUS: 39 86 224 249 336 384 388 532   Allura Xper FD10 722010 S/N:OUS 163 340 1422 1429 1434  Allura Xper FD20 722012 S/N: OUS 395 463 927 1013 1518 2652 2854 2918  Allura Xper FD20 OR Table 722015 S/N: 30 (OUS)  Allura Xper FD10 722026 S/N OUS: 315 701 748 884 888 943 948 960 971 975 978 984 989 995  Allura Xper FD10/10 722027 S/N: OUS 268 278  Allura Xper FD20/10 722029 S/N:OUS 9  Allura Xper FD10 722026 S/N : US 825 959 965 967 985 990 1246  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554  Allura Xper FD10/10 266 722027 S/N: 266  Allura Xper FD20 722028 S/N: 893 UDI: (01)00884838054202(21)893  Allura Xper FD20/10 722029 S/N: 91, 94 US UDI: (01)00884838054219(21)94 OUS:  S/N:6

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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