Z-2643-2026 Class II Ongoing
FDA device recall Z-2643-2026 was initiated by Siemens Medical Solutions USA, Inc on May 20, 2026 and is designated Class II. Reason for recall: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
ARTIS icono floor. Model Number: 11327700.
Reason for Recall
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Distribution Pattern
US Nationwide distribution.
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.