FDA Medical Device Recalls (openFDA)
Stryker Communications Corp: SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, & 067000233. Used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room.
- Recall number
- Z-1644-2010
- Recalling firm
- Stryker Communications Corp
- Product
- SwitchPoint Infinity (SPI) Control System. Catalog Numbers: 067000220, 067000230, 067000231, 067000232, & 067000233. Used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room.
- Status
- Terminated
- Initiated
- 2010-04-15
- Posted
- 2010-05-21
- Terminated
- 2011-01-24
- Reason
- Installation records are incomplete.
- Root cause
- Employee error
- Action
- An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.com.
- Quantity
- 270
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Product installed Between January 1, 2008 and August 31, 2009.
- 510(k) numbers
- ["K031068","K033132"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3002975342
- 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