Z-0528-2007

Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter...

Name: Z-0528-2007 Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter...
Creator: Skytron, Div. The KMW Group, Inc
Published: 2007-01-08
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2007-01-08 / Terminated

FDA source

Skytron, Div. The KMW Group, Inc began a recall of Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made... on 2007-01-08. The reason FDA records is "If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0528-2007
Status: Terminated
Initiated: 2007-01-08
Posted: 2007-02-22
Terminated: 2009-11-18
Recalling firm: Skytron, LLC
Product: Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
Product code: FTD Lamp, Surgical
Reason for recall: If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
FDA 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 in commerce: 5,000 for all models.
Distribution: Nationwide and Canada.
Product codes and lots: Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx).

Product code FTD

K915285Class IISkytron Infinity Series Surgical LightsSkytron, Div. the Kmw Group, Inc. / cleared 1992-02-20

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)