BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system
Medical device recall Z-0356-2022. Published in FDA’s Enforcement Report on Dec 15, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 15, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1201 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
1201 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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 263 264 265 266 267 268…
FDA’s list runs to 37,704 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 12, 2021.
- FDA classified it on Dec 9, 2021.
- FDA’s Enforcement Report published it on Dec 15, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 37,704 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.