Recall Z-0743-2012 ยท DPS Electrocardiograph
Del Mar Reynolds Medical, Ltd.
Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. T
| Date | Jan 13, 2012 (initiated Sep 10, 2010) |
| Status | Terminated |
| Reason | CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). |
| Root cause | Employee error |
| Action | Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to one affected customer in Massachusetts. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to review previous diagnoses made from this electrocardiograph to mitigate any inappropriate recordings or treatment made, and dispose of the mislabeled ECG cable to prevent its use. Spacelabs replaced the affected ECG cable with the new ECG cable. If you have any questions about this corrective action program, please contact Spacelabs Heal |
| Quantity | 15 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090367 | SE-601 SERIES ELECTROCARDIOGRAPH Edan Instruments, Inc., Jun 3, 2009 |