Agency classClass IIOur severity:High FDA (Devices)·Z-0987-2022·Announced 2022-04-27

Siemens Artis pheno diagnostic imaging system software malfunction recall

Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The software malfunction poses a risk of delayed clinical treatment, fitting the criterion of risk-of-harm products where injury has not yet been reported. Since the hazard is theoretical and unaccompanied by actual harm reports, the score is capped at 3 per the rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 20 units of the Artis pheno diagnostic imaging and interventional system. The devices were distributed nationwide and have been identified by specific serial numbers and a Unique Device Identifier (UDI).

The recall is due to five potential software issues affecting the Artis pheno system when used with Siemens Healthineers tables or Trumpf/MAQUET tables. The software errors involve the block movements function and manual rotation of the flat detector.

Depending on the status of the intervention, the limited functionality resulting from these software errors may not be sufficient to continue with planned treatment. This may result in delayed clinical treatment until the system is restarted.

Facilities with affected systems should verify their serial numbers against the FDA recall notice. Healthcare providers should contact Siemens Medical Solutions USA, Inc. for guidance on corrective actions or device replacement.

The recalled product

Product: Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: software-malfunction
functional-impairment
Affected units: 20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

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Same hazard · software malfunction