FDA Device recall Z-2207-2012
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070
- FDA Device
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070 by Philips Healthcare, citing essenta DR C-Arm may fall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2207-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-25 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | CA, NC, TN |
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
Essenta DR C-Arm may fall
Identifiers
| code_info | Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2021-12-01 · Philips Healthcare - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare
All Philips Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2012%22
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