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Showering and changing table 2000

Pressalit A/S · Model R8592418 · UDI-DI 05708590355849

INQ
10
510(k) clearances
47
Adverse events (2 deaths)
2
Recalls
52
Facilities

Description

Showering and changing table 2000, coated canvas, 120V, electrically height adjustable with wired remote control, 1800 mm, with safety rail and water collection tray, white

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.