RecallRadar

FDA Device recall Z-0767-2013

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

On 2013-02-13 the FDA classified a Class II recall of Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications by Philips Healthcare, citing the mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0767-2013
ClassificationClass II
Statusterminated
Initiated2013-01-16
Published2013-02-13
Last updated2026-09-13 11:53 UTC
CompanyPhilips Healthcare
DistributionUS

Product

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

Reason

The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

Identifiers

code_infoSerial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0767-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.