Recall Z-2373-2024— Hologic Inc

Name: FDA recall Z-2373-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-13

Class II · Ongoing

Class II FDA medical device recall by Hologic Inc, initiated 2024-06-13. It names one FDA 510(k) clearance: K023398. Product: Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN. Reason: Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability..

Recalling firm: Hologic Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-06-13
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K023398 — HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERYHologic, Inc.·cleared 2002-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN

Reason for recall

Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.

Data sourced from openFDA. This site is unofficial and independent of the FDA.