The Recall Desk
Severity pendingFDA (Devices)·Z-2662-2025·Announced 2025-10-08

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Pending LLM rewrite. Source: FDA_DEVICE Z-2662-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

The recalled product

Product
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Devices

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 (20)

  • Model Number: 11516217. UDI Numbers: (01)04056869299273(21)212087
  • (01)04056869299273(21)212098
  • (01)04056869299273(21)212088
  • (01)04056869299273(21)212068
  • (01)04056869299273(21)212081
  • (01)04056869299273(21)212018
  • (01)04056869299273(21)212041
  • (01)04056869299273(21)212038
  • (01)04056869299273(21)212047
  • (01)04056869299273(21)212019
  • (01)04056869299273(21)212037
  • (01)04056869299273(21)212032
  • (01)04056869299273(21)212049
  • (01)04056869299273(21)212017
  • (01)04056869299273(21)212064
  • (01)04056869299273(21)212096
  • (01)04056869299273(21)212065
  • (01)04056869299273(21)212016
  • (01)04056869299273(21)212023
  • (01)04056869299273(21)212056

Distribution

Distributed nationwide across the United States.

Related recalls

Same category