Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
FDA device recall Z-0018-05 · posted 2004-10-13 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
- Action taken
- Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
- Root cause
- Other
- Status
- Terminated
- Product code
- NWI
- Quantity affected
- 19
- Distribution
- Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.
- Date initiated
- 2004-09-24
- Date posted
- 2004-10-13
- Date terminated
- 2005-09-15
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIO MONITOR MODEL 0998-00-0600 (K032338) | Datascope Corp. | 2004-02-11 |