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Oakworks Medical
OAKWORKS, INC. · Model Spine Positioning System (SPS) II · UDI-DI 00817463022537
10
510(k) clearances
86
Adverse events
19
Recalls
26
Facilities
Description
For use in diagnostic and therapeutic procedures of the spine. It is intended to be used by a healthcare professional solely for the purpose of aiding in patient positioning and comfort during non-surgical imaging or spinal injection procedures
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2024-05-31 | Siemens Medical Solutions USA, Inc | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| 2022-06-02 | GE Healthcare, LLC | As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the ap |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.