Z-1894-2019Class II
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Siemens Medical Solutions USA, Inc. / initiated 2019-06-06 / Terminated / root cause: design
Siemens Medical Solutions USA, Inc began a recall of Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135 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-1894-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
- 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
- 63
- Distribution
- Nationwide
- Product codes and lots
- Serial Numbers: 135954 136032 136077 136043 136190 136197 136168 136143 136234 136383 136242 136393 136128 136147 136350 136256 136314 136548 136550 136557 136558 137165 137119 136607 137388 137231 137471 137591 137245 137369 137347 137329 137391 137479 137425 124006 138061 137461 137518 137567 137582 137667 137595 137656 138104 138190 124116 137714 124119 138012 138070 138017 138058 138194 138156 138214 138128 138180 138188 138260 138268 138311 138259
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 |
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