Recall record at a glance
| Official record | Z-2120-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ZYTO Technologies, Inc. |
| Report date | Jul 13, 2016 |
| Recall initiation date | Nov 23, 2015 |
| Quantity | 1252 total |
| Location | Lindon, UT, United States |
Official product description
The ZYTO Tower is the input device to program the software with various virtual items.
Why the product was recalled
ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
Distribution information
Nationwide. Canadian and other foreign consignees. No VA/govt/military.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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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