Z-1188-2016Class II

The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record...

Name: Z-1188-2016 The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2016-02-29
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2016-02-29 / Terminated / root cause: manufacturing process

FDA source

Richard Wolf Medical Instruments Corp. began a recall of The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures on 2016-02-29. FDA classified it as Class II and gives the reason as "Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting". 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-1188-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-29
Posted: 2019-07-09
Terminated: 2019-07-03
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
Product code: FWE Camera, Television, Microsurgical, With Audio
Reason for recall: Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: RICHARD WOLF sent an Urgent Safety Information letter dated March 2, 2016, to all affected consignees. The letter described the nature of the recall regarding the monitor holding plate (VESA 75/100 mount) in our Flexion-Port 300, 350 and 400 swivel arm product series. According to the firm insufficient riveting of the rotation elements the rivets may loosen during continuous use (e.g. when adjusting the tilt angle) and in an extremely unlikely event the monitor holding plate (VESA 75/100 mount) may loosen. According to Richard Wolf this can result in a potential danger for the patient, user and others which we want to prevent with this measure. The firm is asking all end users to take the following step: Discontinue use of the affected devices until the conversion kits have been installed by a qualified service technician. Make sure that all users of affected medical devices are informed in their organization of the urgent safety information. If the end user has passed on products to third parties they should pass on a copy of this information and inform the recall contact person at Richard Wolf. Please make sure that the information is observed at their organization until all necessary internal measures have been completed. The end user should provide confirmation of receipt of this urgent safety information and answer the enclosed questionaire form which the firm asks to send to Richard Wolf at the following e-mail, [email protected] by February 22, 2016. The firm asking that recipients to acknowledge receipt of the safety information in order to avoid receiving more reminders from Richard Wolf. The firm will send new monitor holding plate(s}, (643301264 conversion kit for monitor holding plate) once the form is received. The firm asks that qualified service technician install the new monitor holding plate (643301264 Conversion kit for monitor holding plate) in accordance with the enclosed assembly instructions and discard
Quantity in commerce: 108 units
Distribution: Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.
Product codes and lots: FLEXION-PORT 400 (68cm) with Product number 32116068 and the following affected serial numbers: 001X001107, 001X001108, 001X001109, 001X001110, 001X001111, 001X001142, 001X001143, 001X001144, 001X001145, 001X001146, 001X001147, 001X001148, 001X001149, 001X001150, 001X001151, 001X001168, 001X001169, 001X001170, 001X001171, 001X001172, 001X001216, 001X001217, 001X001218, 001X001219, 001X001220, 001X001221, 001X001222, 001X001223, 001X001224, 001X001225, 001X001226, 001X001227, 001X001228, 001X001230, 001X001256, 001X001257, 001X001258, 001X001259, 001X001260, 001X001261, 001X001262, 001X001263, 001X001264, 001X001265, 001X001376, 001X001377, 001X001378, 001X001379, 001X001380, 001X001381, 001X001382, 001X001383, 001X001384, 001X001385 and 001X001229. FLEXION-PORT 300+350 (93cm) with Product number 32116093 and the following affected serial numbers: 001X001173, 001X001174, 001X001175, 001X001176, 001X001177, 001X001235, 001X001237, 001X001239, 001X001299, 001X001309, 001X001310, 001X001313, 001X001314, 001X001315, 001X001366, 001X001367, 001X001368, 001X001369, 001X001370, 001X001371, 001X001372, 001X001373, 001X001374, 001X001375, 001X001402, 001X001403, 001X001406, 001X001231, 001X001232, 001X001233, 001X001234, 001X001236, 001X001238, 001X001240, 001X001296, 001X001297, 001X001298, 001X001300, 001X001301, 001X001302, 001X001303, 001X001304, 001X001305, 001X001306, 001X001307, 001X001308, 001X001311, 001X001312, 001X001404, 001X001405, 001X001439, 001X001440, 001X001441, 001X001442, 001X001443, 001X001444, 001X001445, 001X001446, 001X001447 and 001X001448. FLEXION-PORT 400+350 (103cm) with Product number 32116103 and the following affected serial numbers: 001X001241, 001X001242, 001X001243, 001X001244, 001X001245, 001X001246, 001X001247, 001X001248, 001X001249, 001X001250, 001X001321, 001X001323, 001X001324, 001X001325, 001X001336, 001X001337, 001X001338, 001X001339, 001X001340, 001X001341, 001X001342, 001X001343, 001X001344, 001X001345, 001X001316, 001X001317, 001X001318, 001X001319, 001X001320 and 001X001322.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1188-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1188-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17

Product code FWE

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)