FDA Medical Device Recalls (openFDA)
Stryker Imaging: 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.
- Recall number
- Z-0134-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-08-31
- Posted
- 2009-11-09
- Terminated
- 2010-04-14
- Reason
- Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.
- 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
- 12 devices affected
- Distribution
- Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.
- Lot, serial or model codes
- All accounts that have OfficePACS Power and are enrolled in Guardian Services backup.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMB
- Firm FEI
- 3002907767
- Firm city
- Flower Mound
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28