Recall record at a glance
| Official record | Z-1564-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Hansen Medical Inc. |
| Report date | May 4, 2016 |
| Recall initiation date | Mar 25, 2016 |
| Quantity | 8 kits |
| Location | Mountain View, CA, United States |
Official product description
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
Why the product was recalled
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Distribution information
Nationwide Distribution to OH, TX. FL, CA and GA.
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
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