Recall record at a glance
| Official record | Z-2315-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Toshiba American Medical Systems Inc. |
| Report date | Jul 4, 2018 |
| Recall initiation date | Jan 4, 2018 |
| Quantity | 162 units total |
| Location | Tustin, CA, United States |
Official product description
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Why the product was recalled
The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Distribution information
USA (nationwide) Distribution to the states of : CA, CO, DE, GA, HI, IA, ID, IL, IN, MD, MI, MN, MO, NC, ND, NV, OH, OR, PA, SC, SD, TN, TX, VA, WA, WV and WY.
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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