Hologic - Horizon W X-ray Bone Dxa Systems Wi

Recalling firm
Hologic (Australia and New Zealand) Pty Ltd
Product
Hologic - Horizon W X-Ray Bone DXA Systems WI. [Device]. Model: Part number: Horizon-W. Affected: Lot number: 308911M
Reason
The Horizon WI systems manufactured from 11 December 2024 to 16 January 2025 were shipped without the validated VGA cables. Some installations were completed using VGA cables that may not meet Hologic's applicable performance and safety standards for this system. The impacted units may present a potential risk of elevated Electromagnetic Interference (EMI) to users and/or patients near the affected Horizon DXA systems. The impact can range from user dissatisfaction to delay in treatment and presents an elevated risk of interference to the population of individuals with active, implantable...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-10-27
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/733837fe-0c37-4be4-849b-5560c13efb79