Single and Dual use Emission Computer Tomography gamma cameras — Class II medical device recall Z-1074-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-03-05, distributed nationwide. Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition
| Recall number | Z-1074-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2013-12-19 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, DK, DO, DZ, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IR, IT, JP, KR, LB, LT, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,143 units |
| Serial numbers | 11000003, 11000004, 11000005, 11000006, 11000008, 11000009, 11000011, 11000012, 11000013, 11000014, 11000015, 11000016, 11000017, 11000018, 11000019, 11000020, 11000021, 11000022, 11000023, 11000024, 11000025, 11000026, 11000028, 11000029, 11000030 and 475 more |
Product
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
Reason for recall
Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As
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-1074-2014. 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.