Z-0160-2010

Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers...

Name: Z-0160-2010 Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers...
Creator: Stryker Imaging
Published: 2009-08-03
License: https://open.fda.gov/license/

Stryker Imaging / initiated 2009-08-03 / Terminated

FDA source

Stryker Imaging began a recall of Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad)... on 2009-08-03. The reason FDA records is "Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0160-2010
Status: Terminated
Initiated: 2009-08-03
Posted: 2009-11-10
Terminated: 2010-01-26
Recalling firm: Stryker Imaging
Product: Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.
FDA root cause: Other
Action: Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.
Quantity in commerce: 85
Distribution: Nationwide Distribution
Product codes and lots: All accounts that have OrthoPad and are signed up for 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)