Z-0762-2016Class II
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department
Del Medical, Inc. / initiated 2015-12-03 / Terminated / root cause: manufacturing process
Del Medical, Inc. began a recall of VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department on . FDA classified it as Class II and gives the reason as "The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0762-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Del Medical, Inc.
- Product
- VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
- Product code
- IXY Holder, Radiographic Cassette, Wall-Mounted
- Reason for recall
- The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- The firm sent an email followed by a certified undated letter entitled Safety Related Notification- Field Corrective Action VS-200 and VS-300 Wallstands notifying customers of the recall and actions to be taken. To prevent the possible interruption of service, Del Medical has prepared a service kit which must be installed at the next available opportunity. Del Medical is sending service kits to affected customers. Included within the package will be needed components and, a fixture which will facilitate a one person job. The firm expects the procedure to occupy one hour or, less. Also included with each kit will be an acknowledgement form which is intended to document the fix. The form, along with the original parts are to be returned to Del Medical upon completion of the activity to the following address: Del Medical 241 Covington Drive Bloomingdale, Illinois 60108 Attention: Bill Kostecki 1-847-288-7000
- Quantity in commerce
- 4000
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.
- Product codes and lots
- Product # Serial # 110-5124G1 , 00019-0114 110-5124G1 , 00020-0114 110-5124G1 , 00092-0114 110-5124G1 , 00551-0314 110-5124G1 , 00512-0214 110-5124G1 , 00447-0214 110-5124G1 , 00016-0114 110-5124G1 , 00554-0314 110-5124G1 , 00094-0114 110-5124G1 , 00256-0214 110-5124G1 , 00741-0314 110-5124G1 , 00446-0214 110-5124G1 , 00017-0114 110-5124G1 , 00093-0114 110-5124G1 , 00236-0114 110-5124G1 , 00814-0414 110-5124G1 , 00815-0414 110-5124G1 , 00340-0214 110-5124G3 , 00995-0414 110-5124G1 , 00338-0214 110-5124G1 , 00552-0314 110-5124G1 , 00253-0214 110-5124G1 , 00445-0214 110-5124G1 , 00254-0214 110-5124G1 , 00095-0114 110-5124G1 , 00670-0314 110-5124G1 , 00252-0214 110-5124G1 , 00018-0114 110-5124G1 , 00669-0314 110-5124G1 , 00339-0214 110-5124G1 , 00444-0214 110-5124G1 , 00255-0214
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0761-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0762-2016 | Class II | Terminated | Voluntary: Firm initiated |
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