Z-0134-2010

Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and...

Name: Z-0134-2010 Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and...
Creator: Stryker Imaging
Published: 2009-08-31
License: https://open.fda.gov/license/

Stryker Imaging / initiated 2009-08-31 / Terminated

FDA source

Stryker Imaging began a recall of Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to... on 2009-08-31. The reason FDA records is "Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0134-2010
Status: Terminated
Initiated: 2009-08-31
Posted: 2009-11-09
Terminated: 2010-04-14
Recalling firm: Stryker Imaging
Product: Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan.
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.
FDA root cause: Other
Action: Stryker Imaging issued an "Urgent: Device Correction" notice dated August 18, 2009. Customers were notified of the defective product and informed that Stryker will be in contact shortly to coordinate the product correction. Actions to be taken during the interim were also detailed. For further information, contact Stryker Imaging at 1-972-410-7100.
Quantity in commerce: 12 devices affected
Distribution: Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.
Product codes and lots: All accounts that have OfficePACS Power and are enrolled in Guardian Services backup.

Product code LMB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)