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Oakworks Medical

OAKWORKS, INC. · Model Interventional Supine Pillow System · UDI-DI 00817463022445

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10
510(k) clearances
86
Adverse events
19
Recalls
26
Facilities

Description

Designed to cradle the head, support neck muscles, and improve access during procedures and intended for use by healthcare professional

Recalls

DateFirmReason
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2024-05-31Siemens Medical Solutions USA, IncShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
2022-06-02GE Healthcare, LLCAs 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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Data 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.