Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Pract

FDA device recall Z-0168-2010 · posted 2009-11-10 · Terminated

Recall details

Recalling firm

Stryker Imaging

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LMB

Quantity affected

55 devices affected

Distribution

Nationwide Distribution

Date initiated

2009-07-31

Date posted

2009-11-10

Date terminated

2010-01-08

Location

Flower Mound, TX