Z-2404-2010

Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the...

Name: Z-2404-2010 Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-01-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-01-04 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal... on 2008-01-04. The reason FDA records is "Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2404-2010
Status: Terminated
Initiated: 2008-01-04
Posted: 2010-09-13
Terminated: 2010-09-13
Recalling firm: Philips North America LLC
Product: Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
Product code: IXL Device, Spot-Film
Reason for recall: Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.
FDA root cause: Other
Action: On 1/4/08, the firm issued the URGENT PRODUCT CORRECTION letter dated 1/3/08 to their consignees via certified mail, return receipt requested. The letter informs consignees the issue of the safety switch and counter weight steel band on the Diagnost 55/66/76Plus, Easy Diagnost, and Easy Diagnost Eleva X-ray systems. However, the Easy Diagnost Eleva X-ray system was distributed and applied only to foreign consignees outside US. If the consignees hear the primary steel band clicking/rattling noise while tilting the table to 90 degrees table or positioning the serial changer, the consignees are instructed to tilt the table base towards the 0 degree tilting position and do not use the tilting drive movement until the mandatory action by a Philips service representative has been performed. The Field Change Order (FCO) would be implemented on 01/23/08 and expected to be completed by July 2008. The firm's representatives will visit sites and will inspect all systems where the switch has been replaced or adjusted for proper operation of the safety sensor and switch. Two steel bands will be inspected and replaced if any abnormity is noted. In the mean time, consignees should contact Philips Call Center at 800-722-9377, #5, #2 and reference the FCO 70600029 with any questions.
Quantity in commerce: 28 units
Distribution: Nationwide Distribution
Product codes and lots: Devices are identified as Site Numbers: 73421, 46653, 59224, 62325, 13479, 46954, 25563, 61812, 34800, 13612, 13624, 68220, 35590, 68219, 17576, 59474, 35420, 62630, 44890, 41239, 13691, 59011, 47149, 44888, 6709, 6824, X1007, and X1775.

Product code IXL

K924593Class IIDiagnost 76 Family*r/f Systems - Release 4.4Philips Medical Systems, Inc. / cleared 1992-11-24

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)