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DRGEM

DRGEM Corporation · Model PBT-6 · UDI-DI 08800011101022

IZZ Prescription
10
510(k) clearances
86
Adverse events
19
Recalls
25
Facilities

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.