Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imagin
FDA device recall Z-1148-2018 · posted 2018-03-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
- Action taken
- Siemens sent an Urgent - Medical Device Correction letter dated January 5, 2018. Siemens will conduct an inspection of all affected Artis tables and verify the correct positioning of the bolt as well as the snap rings. The letter recommends the consignees follow Please follow the standard emergency procedures they have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. The Siemens service organization will contact the consignees to arrange a date to perform the corrective action. For further questions, please call (610) 448-6461.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 16
- Distribution
- US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.
- Date initiated
- 2018-01-12
- Date posted
- 2018-03-20
- Date terminated
- 2018-08-28
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ONE (K133580) | Siemens Medical Solutions USA, Inc. | 2014-04-28 |