FDA Medical Device Recalls (openFDA)
Skytron, Div. The KMW Group, Inc: Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.
- Recall number
- Z-0530-2007
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Product
- Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.
- Status
- Terminated
- Initiated
- 2007-01-08
- Posted
- 2007-02-22
- Terminated
- 2009-11-18
- Reason
- If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
- Root cause
- Other
- Action
- The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
- Quantity
- 5,000 for all models.
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx).
- 510(k) numbers
- ["K915285"]
- PMA numbers
- not on file
- Product code
- FTD
- Firm FEI
- 1825014
- Firm city
- Grand Rapids
- Firm state
- MI
- 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