e — Class II medical device recall Z-2758-2016
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2016-09-14, distributed nationwide. "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive.
| Recall number | Z-2758-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States |
| Recall initiated | 2016-08-05 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2018-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, HR, IE, IL, IN, IR, IT, JP, KR, KW, LB, MA, MX, MY, NG, NL, NO, NP, OM, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SV, TH, TN, TR, TT, TW, VN, ZA |
| Quantity | 5,451 |
| Serial numbers | 08501/7823920, 10000, 10001, 10002, 10003, 10005, 10006, 10007, 10008, 10009, 1001, 10010, 10011, 10012, 10013, 10014, 10015, 10016, 10017, 10018, 10019, 1002, 10020, 10022, 10023 and 475 more |
| Model numbers | 10151531, 10151532, 10275879, 10413009, 10520745, 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7761161, 7823920 and 5 more |
Product
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Reason for recall
"We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."
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-2758-2016. 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.