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JUDITTA

ORMESA SRL · Model JUDITTA-45 B30 LIGHT GREY, WHITE FRAME · UDI-DI 08055715701553

INM

510(k) clearances

3,241

Adverse events (13 deaths)

Recalls

189

Facilities

Description

Tilting seating system intended for users with significant systemic, neurological, orthopedic impairment; patients with reduced or no degree of mobility, poor control of the trunk and head, Patients who, due to the permanence in a sitting or lying position, have an average risk index of onset of pressure ulcers (according to the Norton or Braden scale), for which the transpiration of the surfaces (back and seat) is decisive for the maintenance of dry skin, to avoid skin maceration and topical infections. Patients with severe structured spinal deformities, in particular major kyphoscoliosis. Patients with difficulty in controlling and tending to lose the proper position of the pelvis, in order to slide forward.

Recalls

Date	Firm	Reason
2021-11-19	Ki Mobility Llc	The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
2021-07-08	Sunrise Medical (US) LLC	The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-07-08	Sunrise Medical (US) LLC	The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-06-21	Accora Inc	The firm has identified a potential for the backrest to become detached from the chair.
2019-03-28	R82 A/S	Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
2017-06-30	R82 A/S	Replacement campaign on all units that have a gas spring head in aluminum.
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when
2013-09-06	Winco Mfg., LLC	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when

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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.