FDA Medical Device Recalls (openFDA)
Ge Healthcare: Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD
- Recall number
- Z-0601-2010
- Recalling firm
- Ge Healthcare
- Product
- Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD
- Status
- Terminated
- Initiated
- 2009-02-01
- Posted
- 2010-01-27
- Terminated
- 2011-12-31
- Reason
- Failure to properly pre-indicate the technique factors to be used during a patient scan.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.
- Quantity
- 1,764 total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- software versions 12.0, 12.1, 12.2,13.0, & 13.1.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGI
- Firm FEI
- 3005860720
- Firm city
- Wauwatosa
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28