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Recall Observatory FDA recall evidence

Device product

ARTIS icono floor. Model Number: 11327700.

Z-2643-2026

May 20, 2026

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 99079
Status
Ongoing
Classification
Class II
Quantity
30 units
Official record key
device-enforcement:Z-2643-2026

Official wording

Reason: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Code information: Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.