SOMATOM Perspective (Model 10495568)
Medical device recall Z-2474-2018. Published in FDA’s Enforcement Report on Aug 8, 2018.
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 Aug 8, 2018. Copied from openFDA on Oct 20, 2026.
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?
A potential risk of unnecessary radiation exposure due to a software issue
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOMATOM Perspective (Model 10495568)
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 59298 59019 59195 59686 59060 59045 59050 59223 59038 59024 59052 59182 59041 59251 77649 120960 59163 59056 59339 59342 59352 59380 77111 59283 59295 59302 59314 59717 59310 59017 77457 59197 77480 59677 77679 77453 77466 59313…
Every code shown here, 1,995 characters
Serial No. 59298 59019 59195 59686 59060 59045 59050 59223 59038 59024 59052 59182 59041 59251 77649 120960 59163 59056 59339 59342 59352 59380 77111 59283 59295 59302 59314 59717 59310 59017 77457 59197 77480 59677 77679 77453 77466 59313 59278 59400 59023 59166 59702 59043 59383 120977 59317 59164 121003 59657 59018 59221 59034 77432 59353 59267 59237 59029 59681 59330 59359 59189 59051 59042 59389 77130 77591 77560 59344 59204 59350 59343 77578 59049 121004 59288 77523 77557 59218 59225 77403 77411 59207 77532 59268 77549 77428 59320 59293 76954 59021 59324 59362 59708 59354 120987 59663 59228 59010 59200 59653 59672 59222 59206 59710 59391 59376 59242 59358 59031 59355 59674 59390 59690 59185 59346 59048 59258 59703 59260 59719 59671 59334 59323 59169 59374 77410 59246 59284 77107 77110 77581 59011 59030 59369 59224 59290 59312 76953 59171 59304 59289 77465 76973 77460 59249 77598 77119 59255 59393 76939 59377 59259 120978 59240 59168 120963 59167 59365 59658 59216 120982 59713 59716 59704 59654 77525 59013 77387 59162 59190 59366 59348 59692 59047 59230 77308 59394 59025 59061 59064 77121 77123 59378 59172 59699 77521 59285 59274 59318 77573 77506 59301 59287 59282 59676 77516 77527 77541 77675 59698 76944 59006 59008 59028 77489 59231 59711 59335 59662 59382 59336 59696 59714 77440 76933 59349 59385 59248 59065 59205 59700 59341 77493 59328 59668 59257 59239 59236 59303 59165 77488 59209 59351 59679 59020 59275 77672 77599 59281 59181 59361 59399 77397 59233 59238 59243 59037 59261 59685 59300 59707 59188 59036 59327 59022 59040 59256 59381 121007 77444 77454 59666 59252 59035 59709 59254 59005 59183 59277 59016 59684 59396 59363 59397 59046 59372 59694 59667 59215 59286 59291 59053 76936 59271 59660 120950 59305 77101 77322 77357 77392 77531 59027 59032 59220 77595 59715 59184 59387 59270 59273 59280 77602 59279 59689 76950 59321 59340 59203 59661 59316 59229 59272 59214 59245 59364 59683 59235 77621 59682 59326 59331 77623 59059 59311 59292 59219 59306…
FDA’s list runs to 2,168 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.
Nationwide
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Feb 1, 2018.
- FDA classified it on Jul 28, 2018.
- FDA’s Enforcement Report published it on Aug 8, 2018.
- FDA terminated it on May 1, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- 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 2,168 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.