Silhouette VR This fully integrated system offers intuitive controls… — Class II medical device recall Z-1755-2019
Terminated recall by GE Healthcare, LLC, reported 2019-06-19, distributed nationwide. There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related
| Recall number | Z-1755-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-03-29 |
| Classified | 2019-06-10 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2021-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, BG, BR, CA, CN, CR, CY, CZ, DE, DZ, EG, ES, FR, GB, GR, GY, HU, IT, JP, KR, LB, MA, MX, NO, PL, PT, RU, SA, SK, TN, TR, TW, UA, VE, VN |
Product
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Reason for recall
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
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-1755-2019. 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.