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HomeMEDEN INMED SP Z O O › GALAXY TRACTION T3.F0 [SZER 70 CM]

GALAXY TRACTION T3.F0 [SZER 70 CM]

MEDEN INMED SP Z O O · Model 01-STO-3407-003 · UDI-DI 05903684801237

INQ
10
510(k) clearances
47
Adverse events (2 deaths)
2
Recalls
53
Facilities

Description

GALAXY Traction table TTET300, TTET400 is designed to support a patient and the therapist in traction treatment. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient’s spine and traction accessories for lumbar and cervical traction.

Recalls

DateFirmReason
2016-06-29ARJOHUNTLEIGH POLSKA Sp. z.o.o.ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver.
2009-01-26Phillips Nuclear MedicineA problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were

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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.