Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
Recall
- Recall Number
- Z-1054-2019
- Event Number
- 82313
- Firm
- Philips North America, LLC
- FEI Number
- 1218950
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- February 28, 2019
- Terminated
- August 3, 2020
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.
US Nationwide domestic distribution, and worldwide international distribution.
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