Z-0356-2022 Class II Ongoing
FDA device recall Z-0356-2022 was initiated by Philips North America Llc on November 12, 2021 and is designated Class II. 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 r… The recall status is ongoing. Affected quantity: 1201 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 15, 2021
- Initiation Date
- November 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1201 units
Product Description
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
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
Distribution Pattern
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.
Code Information
serial Numbers: 2368 257 252 1234 1139 1989 12662 604 1858 4196 2046 1826 312 313 1360 2438 802 844 1620 3007 2348 318 303 2737 2739 1197 2564 983 236 481 1983 386 13027 74 75 589 693 154 2735 13242 377 798 4466 687 77 565 1101 112 2836 2837 1703 13006 13014 2427 12954 1982 4740 13796 13795 561 13823 13824 597 671 1089 113 1732 13156 1866 2423 1427 325 108 3721 3189 326 3093 603 622 924 282 1984 1152 3009 1059 1136 981 2342 2666 196 73 1650 793 794 799 800 444 3857 289 2866 2020 1138 1547 1548 2708 13604 415 548 3186 2409 2760 3485 3487 2012 48 1869 50 927 193 351 383 384 2811 2821 1885 12566 1937 2365 2810 3078 12618 12619 12620 12621 12622 12623 12624 12625 12626 12628 4080 13051 3534 3301 2279 2385 194 609 52 2185 2311 2366 2177 1461 488 489 492 13519 3568 4758 4759 130 398 3760 2978 3594 1609 1709 2284 4475 285 4390 740 485 2430 38 635 1938 117 13810 3513 13 951 13456 12495 1140 2095 639 1990 2300 1448 897 577 1820 378 259 4381 1744 1745 1746 3512 505 2707 2888 2706 40 1575 2644 2281 1378 2807 1376 12692 1956 535 12895 1148 1987 570 641 366 1438 2526 177 15 2397 1986 3516 2606 644 1734 1735 381 3103 102 514 1085 2003 13402 30 278 1030 1831 139 1586 1567 431 1478 402 806 3058 3962 3963 2266 2227 13326 4022 1487 2338 4094 306 4380 1608 152 12678 3079 591 13394 35 2411 550 2915 1818 121 2704 13072 1048 4320 1677 4137 103 104 111 3190 987 988 2679 64 2410 182 227 2216 92 484 475 1660 1291 58 2465 2843 82 424 2111 13634 2126 1463 2194 2897 2898 2899 2900 2901 1981 1474 2424 1488 1736 1537 2075 3005 437 1797 2819 2437 2822 2431 3632 13312 3495 655 719 33 54 304 307 309 12651 652 879 933 1509 1079 1741 1742 1726 1727 3527 1037 2436 2926 2927 12778 893 2336 886 2282 810 1417 1201 1558 2444 2485 744 273 1049 1424 2667 2668 2169 68 3195 645 62 545 12744 219 2280 766 13381 69 70 623 657 1185 3451 619 1055 213 792 590 12529 12706 684 1470 389 551 1783 3273 3274 1018 3128 564 242 243 938 504 513 1067 3199 411 61 352 12966 1455 926 2025 2617 4077 4772 263 264 265 266 267 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