Reported Jan 19, 2022 · Ongoing
SOMATOM Definition Edge -Computed tomography system Model 10590000
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- SOMATOM Definition Edge -Computed tomography system Model 10590000
- Lot codes and dates
- Serial Numbers
336 of 336 codes
15540384012830478309583915838011553511556581553538382683754832778324983904155521836328374315557883931839791553931553961554131554898323883336839848340184006838341556711556498356215534183564155613835821556068359615559615548515543783934837468323483971155573155335833211554228333215545915538283994830268333015550115563915553583281
- UDIUDI 04056869006949
- Serial Numbers
- Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.