Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional station
FDA device recall Z-2207-2012 · posted 2012-08-15 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Essenta DR C-Arm may fall
- Action taken
- Philips Medical sent an "URGENT FIELD SAFETY NOTICE" dated July 09, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to inspect the C-Arm unit and discontinue use if not parallel to the column, do not use the system and call for a Service Technician. A Field Change Order (FCO) is being released that requires an inspection of C-ARM connection and, if necessary, repair of systems. The bolts will be disconnected and thread inserts will be checked. If not the thread inserts are no longer secured, additional holes will be drilled to use in place of the original ones. For further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 7 units
- Distribution
- Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
- Date initiated
- 2012-07-25
- Date posted
- 2012-08-15
- Date terminated
- 2013-03-01
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS ESSENTA DR (K070528) | Philips Medical Systems GmbH, Dmc | 2007-03-09 |