Recall record at a glance
| Official record | Z-0612-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Philips Medical Systems Gmbh, DMC |
| Report date | Feb 20, 2019 |
| Recall initiation date | Nov 7, 2018 |
| Quantity | 146 |
| Location | Hamburg, N/A, Germany |
Official product description
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Why the product was recalled
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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