Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeeg
FDA device recall Z-1495-2020 · posted 2020-03-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A software issue could potentially cause the stand and table movements to be blocked.
- Action taken
- On February 14, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were informed of the software error which affects the listed systems. In case of software failure, planned procedures may have to be terminated and performed on an alternative x-ray system. Customers were instructed to do the following: Issue # 1: Potential issue with the Message "Stand battery charging: DO NOT POWER OFF" on Artis zeego systems Customer Action: Please check the system messages before power off/shutdown of the system. If possible, do not switch off the system while the message "Stand battery charging: DO NOT POWER OFF" is displayed and wait until the battery has been charged or replaced. Issue # 2: Potential issue of blocked stand movements on Artis zeego systems Issue # 3: Potential issue of blocked table movements on Artis zee/ Q/ Q.zen systems with Siemens Healthineers tables For Issues #2-3, customers may continue to use their systems, but in case the problem occurs, customers are instructed to follow standard emergency procedures in place in the event of system failures. Customers are encouraged to ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the software error via a software update. Siemens' service organization will contact customers to arrange a date to perform this corrective action. For an earlier appointment, please contact the firm's service organization at 1-800-888-7436.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 1452 worldwide (638 US)
- Distribution
- US Nationwide distribuiton.
- Date initiated
- 2020-02-14
- Date posted
- 2020-03-13
- Date terminated
- 2021-04-20
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Artis zee/zeego & Artis Q/Q.zen (K181407) | Siemens Medical Solution USA, Inc. | 2018-08-15 |