Recall Z-2611-2011 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Llc
Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America: 800-522-7025***www.spacelabshealthcare.com***". The Reynolds Pathfinder 700 Holter Analyzer is i
| Date | Jun 22, 2011 (initiated May 24, 2011) |
| Status | Terminated |
| Reason | A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed. |
| Root cause | Software design |
| Action | Spacelabs Healthcare sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 3, 2011 to all customers. The letter describes the product, problem, and the actions to be taken by the customers. Spacelabs Healthcare recommended that until software upgrades can be done, the customers should weigh the benefits versus the risks when deciding whether or not to continue using the product. Spacelabs Healthcare also recommended that customers advise their staff that the second 24 hours of a 48 hour EVO recording would not be analyzed. Field service engineers will be contacting customers to se |
| Quantity | 58 units total (5 units in US and 53 units internationally) |
| Distribution | Worldwide Distribution--USA (nationwide) including states of CA and NC and countries of Czech Republic, Denmark, Hong Kong, Israel, The Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951902 | PATHFINDER 700 HOLTER ANALYZER Reynolds Medical , Ltd., Jul 15, 1996 |