The Recall Desk
HighFDA (Devices)·Z-2447-2021·Announced 2021-09-22

MR MAGNETOM Imaging Systems Risk Data Loss in Treatment Planning

Siemens MR MAGNETOM imaging systems may lose treatment planning data when editing structure sets after reopening a saved study, resulting in incomplete treatment plans being transmitted to planning systems.

What this means for you

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 FDA recall involving potential data loss in a critical medical imaging workflow. Although no illnesses or injuries have been reported, the risk of incomplete treatment planning data being transmitted to treatment systems represents a significant clinical risk.

Plain-English summary

Siemens Medical Solutions USA, Inc is recalling two MR MAGNETOM systems with RT Image Suite (syngo MR VA20A, VA30A, VA31A) identified by Serial Numbers 176302 and 175681.

The systems have a potential for data loss in the contouring or patient marking workflow. When a structure set is edited after the study is saved and reopened, data may be lost, resulting in an incomplete structure set being sent to the treatment planning system.

The affected systems were distributed nationwide in the United States. This is a Class II recall by the FDA.

The recalled product

Product
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device
Hazard
  • data-loss
  • incomplete-medical-data

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 176302 175681

Distribution

Distributed nationwide across the United States.

Related recalls

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