CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
EDAN Telemetry Transmitter recalled by Edan Diagnostics
Edan Diagnostics is recalling EDAN Telemetry Transmitter, distributed nationwide in the US. The recall was initiated on 17 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1256-2020
- FDA event ID
- 84790
- Recalling firm
- Edan Diagnostics, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2017
- FDA classified
- 18 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 17 Nov 2017 | Recall initiated by company | |
| 18 Feb 2020 | Classified by FDA | +823 days |
| 26 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
Where it was distributed
U.S. Nationwide distribution in the state of CA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
Where was it sold?
U.S. Nationwide distribution in the state of CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Edan Diagnostics
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Temperature Abuse | Nationwide |
| Device | CLASS II | EDAN Central Monitoring System recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | EDAN Vital Signs Monitor recalled by Edan Diagnostics | Edan Diagnostics | Other | Nationwide |
| Device | CLASS II | EDAN Vital Signs Monitor recalled by Edan Diagnostics | Edan Diagnostics | Other | Nationwide |
| Device | CLASS II | EDAN Patient Monitor recalled by Edan Diagnostics | Edan Diagnostics | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |