The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyz
FDA device recall Z-1831-2012 · posted 2012-06-20 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.
- Action taken
- Spacelabs Healthcare, Llc sent a "MEDICAL DEVICE CORRECTION" letter dated May 11, 2012 via mailed, return receipt requested, to US customers. The customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. The letter identified the affected product, problem and actions to be taken. Consignees are advised to turn the power off and then on to restore normal functionality. Updated software will be provided upon completion of validation. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 3 for Technical Support.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 114
- Distribution
- Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, S
- Date initiated
- 2012-05-11
- Date posted
- 2012-06-20
- Date terminated
- 2012-10-22
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS PATHFINDER SL HOLTER ANALYZER (K110001) | Spacelabs Healthcare, Ltd. | 2011-06-14 |