Recall Z-1015-04 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies
Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.
| Date | Jul 20, 2004 (initiated Jan 27, 2004) |
| Status | Terminated |
| Reason | The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events. |
| Root cause | Other |
| Action | The firm mailed an 'Urgent Medical Device Correction' letter to consignees on January 27, 2004 advising them of the external electrical noise problem and informing them to not use the Dinalink ILC1931 with patients with pace makers until a fix or replacement can be provided. By 5/17/2004 corrective replacement cables had been provided to all consignees. |
| Quantity | 36 |
| Distribution | Product was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.