Z-0188-2010

XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for...

Name: Z-0188-2010 XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for...
Creator: MAQUET Inc.
Published: 2009-10-07
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2009-10-07 / Terminated / root cause: design

FDA source

MAQUET Inc. began a recall of XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for the examination of the patient on 2009-10-07. The reason FDA records is "Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0188-2010
Status: Terminated
Initiated: 2009-10-07
Posted: 2009-11-12
Terminated: 2012-06-04
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.
Quantity in commerce: 346
Distribution: Nationwide Distribution.
Product codes and lots: Part Number: 567815999.

Product code FSY

K040735Class IIAlm X'ten (X10) Surgical Light SystemAlm S.A. / cleared 2004-05-21

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)