Z-0799-2014Class II

Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS...

Name: Z-0799-2014 Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS...
Creator: Zeiss, Carl Inc
Published: 2013-12-20
License: https://open.fda.gov/license/

Carl Zeiss Microscopy, LLC / initiated 2013-12-20 / Terminated / root cause: manufacturing process

FDA source

Zeiss, Carl Inc began a recall of Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1)... on 2013-12-20. FDA classified it as Class II and gives the reason as "Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0799-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-20
Posted: 2014-01-21
Terminated: 2015-04-08
Recalling firm: Carl Zeiss Microscopy, LLC
Product: Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
Product code: IBJ Light, Microscope
Reason for recall: Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Carl Zeiss, Inc. sent an Important Medical Device Corrective Action letter dated December 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that their service provider would contact them to schedule a visit in which a factory trained service technician would install a new Compensator Slider Lambida 6x20. Customers should return the old Compensator Slider to the factory for testing. Customers with technical questions were instructed to call 914-681-7815.
Quantity in commerce: 335 units Total (14 domestically & 321 internationally)
Distribution: Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
Product codes and lots: part number 473704-0000-000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0799-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0799-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21

Product code IBJ

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)