Data Foundry

Medical device recalls 2013

Philips Easy Upgrade DR — Class II medical device recall Z-2059-2013

Terminated recall by Philips Healthcare Inc., reported 2013-09-04, distributed nationwide. The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication

Recall numberZ-2059-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Healthcare Inc., Andover, MA, United States
Recall initiated2013-08-08
Classified2013-08-26
Reported by FDA2013-09-04
Terminated2020-09-03
DistributedNationwide (US)
Countries outside the USAE, AU, CA, CH, CN, CZ, DE, ES, FR, GB, GR, IT, NL, PT, RU, SA, SE, SI, TR
Quantity89

Product

Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2059-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.