Hidrex USA DVP1000
FDA device recall Z-1237-2017 · posted 2017-02-22 · Terminated
Recall details
- Recalling firm
- Hidrex GmbH
- Reason for recall
- The device was reclassified from a class III device to a class II device and there are new documentation requirements.
- Action taken
- Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- EGJ
- Quantity affected
- 180 units
- Distribution
- Nationwide throughout the US
- Date initiated
- 2017-01-30
- Date posted
- 2017-02-22
- Date terminated
- 2017-08-04
- Location
- Heiligenhaus, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIDREX PSP1000 (K133033) | Hidrex GmbH | 2015-04-08 |