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NOVUS
ORMESA SRL · Model NOVUS-4 TELAIO NERO, TAPPEZZERIA GRIGIO SCURO · UDI-DI 08055715704196
10
510(k) clearances
3,241
Adverse events (13 deaths)
25
Recalls
189
Facilities
Description
Postural reha-buggy intended for teens with important functional impairments, with little or no control of the head and trunk, with little or no functional capacity, who need a particularly robust structure for transport mainly outdoors.
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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Get your free API keyRead the docsData 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.