Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The
FDA device recall Z-0743-2012 · posted 2012-01-13 · Terminated
Recall details
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Reason for recall
- 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).
- Action taken
- 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 Healthcare at 1-800-522-7025 and select 2 for Technical Support.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 15 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-09-10
- Date posted
- 2012-01-13
- Date terminated
- 2012-01-13
- Location
- Hertford, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SE-601 SERIES ELECTROCARDIOGRAPH (K090367) | Edan Instruments, Inc. | 2009-06-03 |