Z-2248-2017Class II

Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local...

Name: Z-2248-2017 Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local...
Creator: Stryker Communications
Published: 2017-04-21
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2017-04-21 / Terminated / root cause: design

FDA source

Stryker Communications began a recall of Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses... on 2017-04-21. FDA classified it as Class II and gives the reason as "The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2248-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-21
Posted: 2017-06-05
Terminated: 2017-09-20
Recalling firm: STRYKER Communications, Inc.
Product: Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
Product code: KZF Device, Medical Examination, Ac Powered
Reason for recall: The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
Root cause tag: design
FDA root cause: Component design/selection
Action: Stryker Communications sent an Urgent Medical Device Recall letter to all affected customers. A Stryker Representative will contact their facility to schedule a service visit. to replace the adapter assembly to resolve the tolerance issue affected units. Customers with questions were instructed to Stryker Technical Support at 800-243-5135 or [email protected]. For questions regarding this recall call 972-834-8656.
Quantity in commerce: 57 units
Distribution: Worldwide Distribution - US and Canada
Product codes and lots: Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2248-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2248-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-05

Product code KZF

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)