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U.S. Department of Health and Human Services

Class 2 Device Recall DynaRad Phantom Portable XRay System

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 Class 2 Device Recall DynaRad Phantom Portable XRay Systemsee related information
Date Initiated by FirmOctober 03, 2006
Date PostedOctober 19, 2006
Recall Status1 Terminated 3 on January 24, 2008
Recall NumberZ-0049-2007
Recall Event ID 36478
510(K)NumberK941363 
Product Classification Portable X-Ray System - Product Code IZL
ProductDynaRad 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)
Code Information 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
Recalling Firm/
Manufacturer		 Del Medical Systems Group
11550 West King Street
Franklin Park IL 60131-1330
For Additional Information ContactMr. William J. Engel
800-800-6006
Manufacturer 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 Determined
Cause 2		Other
ActionDel 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 Commerce53 units
DistributionNationwide and Thailand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZL
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