Z-1388-2019Class II

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the...

Name: Z-1388-2019 EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the...
Creator: Stryker Communications
Published: 2018-11-13
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2018-11-13 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Communications began a recall of EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light... on 2018-11-13. FDA classified it as Class II and gives the reason as "There is a potential the joint in the suspension of the device is insufficiently assembled". 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-1388-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-13
Posted: 2019-05-21
Recalling firm: STRYKER Communications, Inc.
Product: EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: There is a potential the joint in the suspension of the device is insufficiently assembled.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued letters dated 11/13/2018 via FedEx informing to customers. The letter identified the affected product problem and actions to be taken. The customer is asked to disseminate the information within their organization. A response form was enclosed to indicate the customer has read and understands the instructions in the letter. The form was to be returned to the recalling firm via email. Customer was notified that a Stryker representative will begin visiting customer facilities in November to inspect their equipment. For questions contact " Stryker Technical Support at (800) 243-5135 or [email protected]
Quantity in commerce: 3,176 devices
Distribution: Distribution was nationwide, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.
Product codes and lots: Serial numbers 100000000065406 to 100000000106685.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1388-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1388-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-29	2019-05-21

Product code FSY

K060802Class IIVisum LED Surgical Lighting SystemStryker Communications Corp. / cleared 2006-04-07

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)