TomoSPOT REF 782 — Class II medical device recall Z-2832-2018
Terminated recall by Beekley Corporation, reported 2018-08-22, distributed nationwide. There is a potential for imaging artifact to mimic calcifications on patient's mammograms
| Recall number | Z-2832-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beekley Corporation, Bristol, CT, United States |
| Recall initiated | 2018-06-13 |
| Classified | 2018-08-16 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2018-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BH, CA, GB, IL, SA, ZA |
| Quantity | 3,384,024 units |
| Lot numbers | 02061801, 02071802, 02081801, 02121801, 02141801, 02161801, 02211801, 02221801, 02261801, 02261802, 02261803, 02271802, 02271803, 02281801, 03021801, 03021802, 03051801, 03061801, 03071801, 03071802, 03091802, 03121801, 03131801, 03141801, 03141802, 03161801, 03171801, 03211801, 03211802, 03261801, 03271801, 03301802, 04021801, 04051802, 04061801, 04101801, 04111801, 04121801, 04131801, 04161802 and 35 more |
| Model numbers | 782, 782S, 783, 783S, 784, 784S, 785, 785S |
Product
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Reason for recall
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
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-2832-2018. 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.