EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinica
FDA device recall Z-1256-2020 · posted 2020-02-18 · Terminated
Recall details
- Recalling firm
- Edan Diagnostics
- Reason for recall
- Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
- Action taken
- On 11/17/2017, the firm emailed their two Distributors and informed them of the issue and asking them to reply to email. The Recalling Firm instructed its customers/distributors to cease utilization of the affected units and offered to updated the software or have the affected products returned. For any further questions, contact USA based customer service at +1 858 750 3066.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 7 units
- Distribution
- U.S. Nationwide distribution in the state of CA.
- Date initiated
- 2017-11-17
- Date posted
- 2020-02-18
- Date terminated
- 2022-09-28
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Telemetry Transmitter (K161056) | Edan Instruments, Inc. | 2017-02-03 |