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Spex Limited

SPEX LIMITED · Model PROMO-ATPKIT-14 · UDI-DI 09420051798632

KNNKNOIMS
10
510(k) clearances
291
Adverse events (11 deaths)
11
Recalls
140
Facilities

Description

Spex Assistive Technology Professional (ATP) Accessory Kit - Paediatric 14" Kit Incudes 1259-2400-100 Spex Back Support Quad Mount Hardware 1266-2501-100 Axial Biangular Lateral Bracket (for use with Axial Biangular Lateral Pad) 1266-2301-100 Spex Swing-Away Lateral Bracket, Axial; includes protective neoprene sleeve 1274-1282-000 Stylo 260 Fixed Extended Mechanism 1250-3955-000 TSS Lite Contouring Kit 1266-3012-400 Narrow Straight lateral pad with standard cover, size 2; 95mm high x 180mm deep 1266-3012-800 Narrow Straight lateral pad with Comfy-cover, size 2; 95mm high x 180mm deep 1266-3044-400 Axial Biangular Lateral Pad Size 4, with 12mm Pressure Reduction padding, Standard cover 1275-0043-000 Spex Standard Lateral Head Support Head Support pad (000 Black) 1400-6692-000 Spex Shoulder Strap Guides/Retainer, Pair

Recalls

DateFirmReason
2026-06-19MUNEVO GMBHA software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control
2025-07-10mo-Vis BVBADevices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair
2025-07-10mo-Vis BVBADevices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair
2025-07-10mo-Vis BVBADevices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair
2025-07-10mo-Vis BVBADevices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair
2025-07-10mo-Vis BVBADevices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair
2025-07-10mo-Vis BVBADevices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair
2023-11-28mo-Vis BVBAIn rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwan
2023-07-06Aquila CorporationDefective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
2023-07-06Aquila CorporationDefective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.

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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.