GE Optional Laser Centering Device X-ray generator — Class II medical device recall Z-2320-2015
Terminated recall by GE Inspection Technologies, LP, reported 2015-08-19, distributed in AL, CA, FL, LA, MD, NY, PA, WA. GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignm
| Recall number | Z-2320-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Inspection Technologies, LP, Lewistown, PA, United States |
| Recall initiated | 2014-11-10 |
| Classified | 2015-08-13 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2017-02-01 |
| Distributed | AL, CA, FL, LA, MD, NY, PA, WA |
| Quantity | 25 |
| Model numbers | 025.03.00A |
Product
GE Optional Laser Centering Device X-ray generator.
Reason for recall
GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
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-2320-2015. 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.