Z-0369-05

Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811

Name: Z-0369-05 Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2004-12-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-12-01 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811 on 2004-12-01. The reason FDA records is "X-Ray system may fall downward and could possibly hit the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0369-05
Status: Terminated
Initiated: 2004-12-01
Posted: 2004-12-24
Terminated: 2006-02-10
Recalling firm: Philips North America LLC
Product: Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
Product code: KPR System, X-Ray, Stationary
Reason for recall: X-Ray system may fall downward and could possibly hit the patient.
FDA root cause: Other
Action: A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.
Quantity in commerce: 44 total units (Thoravision I and II)
Distribution: The firm distributed this product to hospitals and medical centers nationwide.
Product codes and lots: The firm uses site numbers instead of serial numbers. The listed site numbers include both Thoravision I and II products. 83956, 13253, 13917, 86223, 25709, 38975, 17579, 13610, 17506, 50321, 100322, 13919, 45032, 44803, 26294, 82617, 76802, 100633, 41354, 26058, 100693, 76806, X0212, 62971, 76374, 59408, 6960, 38715, 10405, 40932, 50319, 50320, 59670, 62972, 86451, X1068, 47101, 47167, 17620, 26214, 76020, 76021, 41437, 38989.

Product code KPR

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)