Date Initiated by Firm |
February 02, 2009 |
Date Posted |
April 27, 2009 |
Recall Status1 |
Terminated 3 on June 04, 2009 |
Recall Number |
Z-1123-2009 |
Recall Event ID |
51276 |
Product Classification |
Electrical Operating-Room Table - Product Code GDC
|
Product |
Operon Electrical Operating Room Table.
The device is used as an electrical operating room table. |
Code Information |
D 850, D750, D 752 and B 810. |
Recalling Firm/ Manufacturer |
Berchtold Corp. 1950 Hanahan Rd N Charleston SC 29406-4878
|
For Additional Information Contact |
Heath Hines 800-243-5135 Ext. 263
|
Manufacturer Reason for Recall |
Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece.
|
FDA Determined Cause 2 |
Device Design |
Action |
An official notification letter dated February 3, 2009 was hand-carried by a local Berchtold Corporation Technical Service representative to each account. The letter indicated that the Berchtold Corporation Service Technician will complete recommended upgrades. Direct questions concerning this recall to your BERCHTOLD Technician Service at 1-800-243-5135 and press the Number 2. |
Quantity in Commerce |
453 units |
Distribution |
Worldwide Distribution -- US and Canada. |
Total Product Life Cycle |
TPLC Device Report
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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.
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