Z-1898-2019Class II
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Siemens Medical Solutions USA, Inc. / initiated 2019-06-06 / Terminated / root cause: design
Siemens Medical Solutions USA, Inc began a recall of Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280 on . FDA classified it as Class II and gives the reason as "Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1898-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
- Product code
- OWB Interventional Fluoroscopic X-Ray System
- Reason for recall
- Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Siemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.
- Quantity in commerce
- 12
- Distribution
- Nationwide
- Product codes and lots
- Serial Numbers: 103008 103030 103028 103258 103221 103222 103277 103220 103279 103285 103286 103295
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1894-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1895-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1896-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1897-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1898-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1899-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1900-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1901-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1902-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1903-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1904-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1905-2019 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.