Artis Q and Q — Class II medical device recall Z-0709-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-03-07, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electr
| Recall number | Z-0709-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2017-09-28 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-03-09 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Quantity | 1,557 |
| Serial numbers | 10000, 10003, 10006, 10007, 10008, 10009, 10012, 10014, 10020, 10021, 10022, 10024, 10025, 10029, 10031, 10036, 10038, 10039, 10041, 10042, 10045, 10046, 10050, 10052, 10056 and 475 more |
| Model numbers | 4787797, 4787805, 4787813 |
Product
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Reason for recall
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0709-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.