FDA Medical Device Recalls (openFDA)
Del Medical Systems Group: Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
- Recall number
- Z-0816-05
- Recalling firm
- Del Medical Systems Group
- Product
- Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
- Status
- Terminated
- Initiated
- 2005-03-10
- Posted
- 2005-05-11
- Terminated
- 2005-11-14
- Reason
- 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
- 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
- 31 stands
- Distribution
- Nationwide, Mexico and Thailand.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYB
- Firm FEI
- 1418964
- Firm city
- Franklin Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28