Recall Z-1831-2012 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Llc
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cu
| Date | Jun 20, 2012 (initiated May 11, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110001 | SPACELABS PATHFINDER SL HOLTER ANALYZER Spacelabs Healthcare, Ltd., Jun 14, 2011 |