Z-0816-05

Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin...

Name: Z-0816-05 Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin...
Creator: Del Medical Systems Group
Published: 2005-03-10
License: https://open.fda.gov/license/

Del Medical, Inc. / initiated 2005-03-10 / Terminated / root cause: manufacturing process

FDA source

Del Medical Systems Group began a recall of Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131 on 2005-03-10. The reason FDA records is "The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0816-05
Status: Terminated
Initiated: 2005-03-10
Posted: 2005-05-11
Terminated: 2005-11-14
Recalling firm: Del Medical, Inc.
Product: Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
Product code: IYB Tube Mount, X-Ray, Diagnostic
Reason for recall: The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Del Medical sent Field Correction Recall letters dated 3/10/05 to the direct accounts, informing them of the potential for a defective weld supporting the braket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly 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: 31 stands
Distribution: Nationwide, Mexico and Thailand.
Product codes and lots: All Phantom Model Tube Stands with squared corners on all four corners of the stand. Catalog #501031, serial numbers 00743-0204, 00778-0204, 00997-0304, 01001-0304, 01103-0304, 01293-0304, 01371-0304, 01425-0404, 01452-0404, 01470-0404, 01475-0404, 01575-0404, 01592-0404, 01700-0404, 01704-0404, 01790-0404, 01841-0404, 01851-0404, 01898-0504, 02019-0504, 02023-0504, 02051-0504, 02096-0504, 02178-0504, 02188-0504, 02310-0604, 02357-0604, 02429-0604, 02517-0604, 02534-0604, 02584-0604, 02671-0604, 02752-0704, 02760-0704, 02776-0704, 02839-0704, 02891-0704, 02928-0704, 02938-0704, 02945-0704, 02959-0704, 02980-0704, 02991-0704, 03076-0704, 03084-0704, 03122-0704, 03375-0804, 03455-0804, 03476-0804, 03518-0804, 03543-0804, 03570-0904, 03579-0904, 03636-0904, 03700-0904, 03708-0904, 03722-0904, 03740-0904, 03952-0904, 04037-0904, 04134-1004, 04183-1004, 04347-1004, 04380-1004, 04407-1004, 04477-1004, 04481-1004, 04491-1004, 04524-1004, 04534-1004, 04592-1104, 04600-1104, 04605-1104, 04648-1104, 04694-1104, 04699-1104, 04703-1104, 0439-1104, 04783-1104, 04862-1104, 05190-1204, 05194-1204, 05198-1204, 05216-1204, 05364-1204, 05414-1204, 05418-1204, 05439-1204, 00283-0105, 00340-0105, 00481-0105, 00571-0205, 00575-0205, 00617-0205, 00649-0205, 00763-0205, 00841-0205, 00858-0205, 00891-0205, 00900-0205, 00913-0205

Product code IYB

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)