Prodigy F2Recalls & reported problems
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC · Assy, Warehouse Ready, P11 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682138345), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K133664, K161682, K191112, K982267); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Device Handling Problem; Device Handling Problem
ON (B)(6) 2025, (B)(6) REPORTED AN INCIDENT INVOLVING A PRODIGY DENSITOMETRY SYSTEM PHANTOM. DURING HANDLING, THE PHANTOM WAS ACCIDENTALLY DROPPED, STRIKING THE OPERATORÂ'S FOOT, CAUSING A FRACTURE IN THE RIGHT FOOT BIG TOE. NO DEVICE MALFUNCTION WAS REPORTED; THE EVENT OCCURRED DURING ROUTINE HANDLING OF THE PHANTOM. ALTHOUGH THE INJURY OCCURRED ON (B)(6) 2025, THE CUSTOMER DID NOT INFORM GE HEALTHCARE UNTIL 10-DEC-2025.
Patient problems: Bone Fracture(s)
MAUDE report 23868757 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133664, K161682, K191112, K982267. One submission often covers many models, so check the product and lot details in each record.
- Z-1710-2020 · Dec 3, 2019 · Open, ClassifiedLunar iDXA Advance (iDXA with enCORE v16) bone densitometer
- Z-1711-2020 · Dec 3, 2019 · Open, ClassifiedLunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
- Z-1712-2020 · Dec 3, 2019 · Open, ClassifiedLunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
- Z-1395-2018 · Mar 16, 2018 · TerminatedGE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Ad
Other Densitometer, bone devices
- Horizon AHologic, Inc. · Densitometer, bone1 recall3 reports
- Horizon WHologic, Inc. · Densitometer, bone1 recall1 report
- Horizon CiHologic, Inc. · Densitometer, bone1 recall1 report
- Horizon WiHologic, Inc. · Densitometer, bone1 recall0 reports
- Horizon CHologic, Inc. · Densitometer, bone1 recall0 reports
- Discovery WiHologic, Inc. · Densitometer, bone5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.