BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling the BV Pulsera with Software Release 2.3-A mobile diagnostic X-ray system (Model 718095) because its Instructions for Use do not specify the maximum surface temperature of the X-ray tank and image intensifier/detector. The X-ray tank is the assembly that houses the X-ray tube, beam filter, and cooling oil. Without this temperature information, users may not be aware of burn hazards from these hot surfaces.
Approximately 1,201 units of this system have been distributed worldwide, including throughout the United States and numerous other countries. The recall affects units with specific serial numbers listed in the distribution record. 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.
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
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: 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 G Quantity: 1201 units Lot/code info: 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 14
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.