Z-0370-05

Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812

Name: Z-0370-05 Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812
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 II Thorax and Mass Chest Column. Part numbers 4512 130 07812 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-0370-05
Status: Terminated
Initiated: 2004-12-01
Posted: 2004-12-24
Terminated: 2006-02-10
Recalling firm: Philips North America LLC
Product: Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
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: See the site numbers listed for the Thoravision I. The listed site numbers include both Thoravision I and II products.

Product code KPR

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)