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FDA (Device enforcement)Recalled 2021-11-24class ii

Philips North America Llc: 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: 72200

Is my product affected?

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, 7220

  • UPC 00884838054189
  • UPC 00884838054202
  • UPC 00884838054219

Check against the official notice below — it lists the full affected range.

What happened

Philips North America LLC is recalling certain Philips Allura Xper interventional fluoroscopic X-ray systems (Model 72200) equipped with a Laird chiller that lacks an extended drip tray. The systems have a potential leak in the detector cooling system that could allow cooling liquid to escape outside the chiller's drip tray. If this occurs, the liquid could drip onto electrical components in the R cabinet located in the technical room, potentially damaging the system and causing thermal events such as burning odors, smoke, or fire. The recall affects 63 systems in the United States and 127 systems in other countries worldwide, including Argentina, Austria, Brazil, China, France, Germany, Japan, Mexico, Spain, the United Kingdom, and many others.

The specific affected systems are identified by model number and serial number in the recall documentation. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. 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.) Quantity: USA: 63 systems R.O.W.: 127 systems Lot/code info: 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 19

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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