Philips Essenta DR — Class II medical device recall Z-0584-2014

Terminated recall by Philips Medical Systems, Inc., reported 2014-01-08, distributed nationwide. X-ray system C-arm casting may loosen and fall

Recall number	`Z-0584-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Philips Medical Systems, Inc., Andover, MA, United States
Recall initiated	2013-12-05
Classified	2013-12-27
Reported by FDA	2014-01-08
Terminated	2017-01-17
Distributed	Nationwide (US)
Countries outside the US	AF, AR, AU, BG, BR, CA, CL, CN, CO, CZ, DE, EG, ES, FR, GB, GR, HU, ID, IN, IR, IT, JO, KE, KR, LT, MA, NG, NL, NZ, PL, PT, RU, SA, SE, SG, SK, TH, TR, UA, VN
Quantity	424 units
Model numbers	`712070`

Product

Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.

Reason for recall

X-ray system C-arm casting may loosen and fall

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-0584-2014. 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.