Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2016-12-13 | Z-0992-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 41 units | clearance family |
| 2016-12-13 | Z-0993-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 34 units | clearance family |
| 2016-12-13 | Z-0994-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 71 units | clearance family |
| 2016-12-13 | Z-0995-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 88 units | clearance family |
| 2016-12-13 | Z-0996-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 102 units | clearance family |
| 2016-12-13 | Z-0997-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 18 units | clearance family |
| 2016-12-13 | Z-0998-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 1 unit | clearance family |
| 2016-12-13 | Z-0999-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 1 unit | clearance family |
| 2016-12-13 | Z-1000-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 51 units | clearance family |
| 2016-12-13 | Z-1001-2017 | Class II | Terminated | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.Distribution: Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW. | 1 unit | clearance family |
Showing 1–10 of 11
Regulatory clearances
- 510(k)K151486Substantially equivalent (SESE) · 2015-07-17clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-01-31 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2024-01-31 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2023-01-06 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 5 |
| 2023-01-06 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 5 |
| 2022-10-26 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc | 3 |
| 2019-09-18 | NAI | No action indicated | Siemens Medical Solutions USA Inc | 0 |
| 2019-06-10 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-10 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-07 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-07 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2019-06-06 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2017-04-27 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2016-04-15 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 2 |
| 2015-09-09 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2015-09-09 | NAI | No action indicated | Siemens Medical Solutions USA, Inc. | 0 |
| 2015-03-27 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 6 |
| 2014-12-12 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2014-12-12 | VAI | Voluntary action indicated | Siemens Medical Solutions USA, Inc. | 1 |
| 2014-11-07 | NAI | No action indicated | Siemens Medical Solutions USA, Inc | 0 |
| 2014-07-25 | NAI | No action indicated | Siemens Medical Solutions USA Inc | 3 |
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