CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report

Somatom Definition Flash recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Definition Flash (, distributed in District of Columbia, Puerto Rico. The recall was initiated on 8 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075 73099 73544 73648 74156 73734 73343 73374 73726 73526 73636 73346 73518 74207 73258 74054 73860 73579 73813 73930 73120 73108 74360 73054 74128 74926 73679 73427 98600 73622 73533 73621 73423 73424 73493 73520 73718 73459 73372 73637 73303 73296 73349 74924 74927 73786 73240 73279 73278 74374 73531 73760 73831 73224 73820 74042 73840 74191 73832 73152 74117 74118 74405 73673 73651 73352 73044 74456 73487 73492 73494 73497 73016 73711 74929 73310 73409 73778 73935 73642 73709 73722 74240 73130 73013 73657 73300 73499 73535 73090 98607 73377 73031 73355 73777 98617 73330 73883 73366 73783 73036 73623 73908 74978 73667 73285 73281 73141 73684 73248 74391 74209 73490 74399 73461 73428 73791 73455 73191 73887 73071 98606 74094 98601 74098 74045 74363 73758 73513 74368 73368 73035 73895 73297 73182 73122 74262 74116 73253 73337 73375 74158 74153 73153 73545 74192 98613 74925 73670 73361 74226 74297 74234 74364 74376 73162 73262 73328 73241 73683 74048 74068 73320 73697 73635 73405 73471 74912 73160 73600 73742 73030 73655 73931 73921 73818 73873 73028 74145 73155 73591 74904 73905 73938 98605 73244 73546 74922 73478 73547 73442 73886 73504 73413 73674 73514 73464 73445 74129 73538 73420 73904 74093 73127 73185 73268 73761 74200 74289 74062 73521 73522 73261 73357 73430 74251 73235 73911 73574 73061 73604 74152 73151 73225

Quantity recalled238

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1747-2018
FDA event ID: 79295
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 8 Nov 2017
FDA classified: 15 May 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

8 Nov 2017	Recall initiated by company
15 May 2018	Classified by FDA	+188 days
23 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system

Where it was distributed

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

District of Columbia Puerto Rico

Questions about this recall

Is Somatom Definition Flash ( recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Definition Flash ( on 8 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-1747-2018.

Why was it recalled?

Which lots are affected?

Serial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075 73099 73544 73648 74156 73734 73343 73374 73726 73526 73636 73346 73518 74207 73258 74054 73860 73579 73813 73930 73120 73108 74360 73054 74128 74926 73679 73427 98600 73622 73533 73621 73423 73424 73493 73520 73718 73459 73372 73637 73303 73296 73349 74924 74927 73786 73240 73279 73278 74374 73531 73760 73831 73224 73820 74042 73840 74191 73832 73152 74117 74118 74405 73673 73651 73352 73044 74456 73487 73492 73494 73497 73016 73711 74929 73310 73409 73778 73935 73642 73709 73722 74240 73130 73013 73657 73300 73499 73535 73090 98607 73377 73031 73355 73777 98617 73330 73883 73366 73783 73036 73623 73908 74978 73667 73285 73281 73141 73684 73248 74391 74209 73490 74399 73461 73428 73791 73455 73191 73887 73071 98606 74094 98601 74098 74045 74363 73758 73513 74368 73368 73035 73895 73297 73182 73122 74262 74116 73253 73337 73375 74158 74153 73153 73545 74192 98613 74925 73670 73361 74226 74297 74234 74364 74376 73162 73262 73328 73241 73683 74048 74068 73320 73697 73635 73405 73471 74912 73160 73600 73742 73030 73655 73931 73921 73818 73873 73028 74145 73155 73591 74904 73905 73938 98605 73244 73546 74922 73478 73547 73442 73886 73504 73413 73674 73514 73464 73445 74129 73538 73420 73904 74093 73127 73185 73268 73761 74200 74289 74062 73521 73522 73261 73357 73430 74251 73235 73911 73574 73061 73604 74152 73151 73225

Where was it sold?

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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