Z-2341-2012Class II

Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system

Name: Z-2341-2012 Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-04-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-04-30 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system on 2012-04-30. FDA classified it as Class II and gives the reason as "Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may...". 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-2341-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-30
Posted: 2012-09-10
Terminated: 2012-09-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent a Update instructions letter dated April 2012, to all affected customers. The safety instruction letter identified the product the problem and the action needed to be taken by the customer. The update has been completed successfully. The customer has been informed of the benefits of improvements resulting from this update. Further questions please call (610) 219-4834.
Quantity in commerce: 5
Distribution: Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.
Product codes and lots: Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2341-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2341-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10

Product code JAA

K010942Class IIU04Siemens Medical Solutions USA, Inc. / cleared 2001-04-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)