Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0168-2010 · Posted 2009-11-10

Recalling FirmStryker Imaging
Recall StatusTerminated
Product CodeLMB
Date Initiated2009-07-31
Date Terminated2010-01-08
Product Quantity55 devices affected

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑