ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition
FDA device recall Z-0054-2007 · posted 2006-10-21 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur.
- Action taken
- An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 379
- Distribution
- Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
- Date initiated
- 2006-06-23
- Date posted
- 2006-10-21
- Date terminated
- 2007-05-25
- Location
- Wauwatosa, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEXPRO FH TELEMETRY SYSTEM (K033365) | Ge Medical Systems Information Technologies | 2003-11-06 |