Z-2210-2010

Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage...

Name: Z-2210-2010 Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-06-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-06-26 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold... on 2008-06-26. The reason FDA records is "Monitor ceiling carriage may separate from the monitor ceiling suspension". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2210-2010
Status: Terminated
Initiated: 2008-06-26
Posted: 2010-08-11
Terminated: 2010-12-02
Recalling firm: Philips North America LLC
Product: Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Monitor ceiling carriage may separate from the monitor ceiling suspension.
FDA root cause: Other
Action: On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.
Quantity in commerce: 1111 units
Distribution: United States and Canada.
Product codes and lots: Products are identified as Equipment numbers: 13046, 25934, 34702, 38592, 41455, 44791, 45059, 52463, 62671, 82824, 83667, 85095, 85137, 85190, 85195, 86189, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101036, 101077, 101612, 101952, 102664, 103147, 103238, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104497, 104670, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 105960, 203880, 215045, 215140, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505064, 505077, 505111, 505111, 505252, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505858, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506778, 519115, 519118, 519136, 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Product code IZI

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