Z-1506-2024Class II

Chromophare Surgical Light System , REF CH00000001

Name: Z-1506-2024 Chromophare Surgical Light System , REF CH00000001
Creator: Stryker Communications
Published: 2024-02-08
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2024-02-08 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Communications began a recall of Chromophare Surgical Light System , REF CH00000001 on 2024-02-08. FDA classified it as Class II and gives the reason as "Due to insufficient mounting force the stability of surgical light system cannot be guaranteed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1506-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-08
Posted: 2024-04-09
Recalling firm: STRYKER Communications, Inc.
Product: Chromophare Surgical Light System , REF CH00000001
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On February 19, 2024, Stryker issued a Urgent Medical Device Recall notification via XXX. In addition to notifying consignees about the recall. Stryker asked consignees to take the following actions: Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the product listed in the product affected grid. If affected product is found, segregate and do not use the product. 3. Complete and sign the enclosed Business Reply Form on Attachment A and return to [email protected]. 4. A Sales Representative or Field Service Technician will be in contact with your facility to schedule a service visit to perform the recall activities. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.
Quantity in commerce: 1 unit
Distribution: US: None OUS: Chili
Product codes and lots: S/N:03857056/ UDI: 07613327296167

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-09

Product code FSY

K120392Class IIChromophare F 628 and F 528Berchtold GmbH & Co. KG / cleared 2012-02-16

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)