Stationary Fluoroscopic X-ray System CombiDiagnost R90 recall
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Why was Stationary Fluoroscopic X-ray System CombiDiagnost R90 recalled?
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
- Product
- Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Quantity
- 146
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
- Recall date
- February 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)