PowerLook AMP SLD GE US V7.2Recalls & reported problems

Icad, Inc. · The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858012005014), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Problem with Software Installation” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Problem with Software Installation1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 11, 2018Problem with Software Installation; Problem with Software Installation
A CUSTOMER SITE INDICATED THAT NO CAD MARKINGS WERE REPORTED FROM THE CAD AFTER PROCESSING PATIENT IMAGES. THE OEM MAMMOGRAPHY FIELD SERVICE ENGINEER (FSE) DID NOT APPLY THE CAD LICENSE AFTER INSTALLING THE CAD SOFTWARE. THIS RESULTED IN THE SITE NOT HAVING CAD MARKS ON CASES FOR SOME TIME. NO PATIENT INJURY OR ADVERSE EVENT WAS ASSOCIATED WITH THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7183668 ↗

Device details

UDI-DI	`00858012005014`
Brand	PowerLook AMP SLD GE US
Model	V7.2
Catalog no.	DSC010-01-US
Company	Icad, Inc.
Product code	MYN · Analyzer,Medical Image
Class	Class 2
FDA submission	P010038
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Basic diagnostic x-ray system application software

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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