Z-0049-2007

DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin...

Name: Z-0049-2007 DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin...
Creator: Del Medical Systems Group
Published: 2006-10-03
License: https://open.fda.gov/license/

Del Medical, Inc. / initiated 2006-10-03 / Terminated

FDA source

Del Medical Systems Group began a recall of DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM &... on 2006-10-03. The reason FDA records is "The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0049-2007
Status: Terminated
Initiated: 2006-10-03
Posted: 2006-10-19
Terminated: 2008-01-24
Recalling firm: Del Medical, Inc.
Product: DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)
Product code: IZL System, X-Ray, Mobile
Reason for recall: The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.
FDA root cause: Other
Action: Del Medical sent Field Correction Recall letters dated 10/3/06 to the direct accounts, informing them of the potential for the shoulder bolt in the yoke assembly to come loose. If the shoulder bolt comes loose, the tube head could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.
Quantity in commerce: 53 units
Distribution: Nationwide and Thailand
Product codes and lots: Generator serial numbers: 03460-1003, 03477-1003, 03499-1003, 03550-1003, 03647-1003, 03704-1003, 03734-1003, 03744-1003, 03759-1003, 03765-1003, 03823-1003, 03938-1103, 03941-1103, 03953-1003, 04227-1103, 04282-1203, 04303-1203, 04330-1203, 04477-1203, 04497-1203, 04666-1203, 04704-1203, 00013-0104, 00035-0104, 00107-0104, 00122-0104, 00127-0104, 00188-0104, 00192-0104, 00332-0104, 00336-0104, 00405-0104, 00417-0104, 00430-0104, 00474-0104, 00545-0204, 00555-0204, 00568-0204, 00709-0204, 00719-0204, 00741-0204, 00754-0204, 00776-0204, 00995-0304, 00999-0304, 01101-0304, 01291-0304, 01295-0304, 01369-0304, 01423-0404, 01450-0404, 01468-0404, 01473-0404

Product code IZL

K941363Class IIPhantomDynarad Corp. / cleared 1994-07-20

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)