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

FDA device recall Z-2373-2024 · posted 2024-07-16 · Open, Classified

Recall details

Recalling firm

Hologic Inc

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.

Action taken

***August 16, 2024 UPDATE*** After further review of the install base for systems in scope of the Horizon recall, updates made to the consignee list. From the original list, 270 systems have been identified to be out of scope of this recall. Additionally, 44 systems were identified to be in scope of the recall that were not on the original consignee list. Customer notifications for the additional 44 in scope systems were distributed on 8/13/2024. RES Updated Serial numbers. Hologic issued URGENT: MEDICAL DEVICE CORRECTION FA-00247 Letter on 6/26/24. Letter states reason for recall, health risk and action to take: Recommendations: " Do NOT scan patients that have active implanted medical devices, including but not limited to neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors. " Any operator who has an active implanted medical device should also refrain from operating the system at this time. " Do NOT scan patients that are currently being treated with an electronic medical device. " Extend this communication to all pertinent staff in interaction and/or use with the Horizon DXA System. " Until the correction is completed, this letter and the specific warning below supersedes information provided on the Horizon DXA labeling and IFU pertaining to electromagnetic compatibility and electromagnetic interference. Rectification activity by Hologic: We are urgently investigating the permanent rectification actions required, and we will be in contact promptly once this is defined. A service appointment will be scheduled for the remediation activity. As additional clarification regarding the continued safe use of your Horizon DXA system, please note the following: This notice pertains to electromagnetic emissions, not ionizing radiation. Electromagnetic emissions are emitted by all electronic devices, such as cell phones, lights, computers, TVs, medical devices, among others. Further, please note that elec

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KGI

Quantity affected

2,642 units (1037 units US; 1605 units OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias, Andorra, Switzerland, Taiw

Date initiated

2024-06-13

Date posted

2024-07-16

Location

Newark, DE

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