FDA Device

Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.

Hazard

Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis.

What You Should Do

Remedy

Firm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.

Products

Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disast
Brand
Stryker Imaging
UPC
All accounts that have NetPractice and are signed up for Guardian Services backup.

Units Affected

55 devices affected