Philips Essenta DR — Class II medical device recall Z-2207-2012
Terminated recall by Philips Healthcare Inc., reported 2012-08-22, distributed in CA, NC, TN. Essenta DR C-Arm may fall
| Recall number | Z-2207-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-07-25 |
| Classified | 2012-08-15 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2013-03-01 |
| Distributed | CA, NC, TN |
| Countries outside the US | CN, DE, HU |
| Quantity | 7 units |
| Serial numbers | SN08000050, SN08000092, SN09000006, SN09000007, SN10000014, SN10000033, SN100000654 |
| Model numbers | 712070 |
Product
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): 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 arm.
Reason for recall
Essenta DR C-Arm may 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-2207-2012. 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.