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U.S. Department of Health and Human Services

Class 2 Device Recall Richard Wolf Medical Instrument Corp. ICart

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  Class 2 Device Recall Richard Wolf Medical Instrument Corp. ICart see related information
Date Initiated by Firm December 10, 2014
Date Posted March 03, 2015
Recall Status1 Terminated 3 on July 31, 2017
Recall Number Z-1240-2015
Recall Event ID 70220
Product Classification Monitor, bed patient - Product Code KMI
Product The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Code Information (NOTE: The listed serial numbers are for the carts manufactured and include those that were distributed.)   1) Part Number: 31113.801; Serial Numbers: 1306000, 1306007, 1306014, 1306021, 1306103, 1306001, 1306008, 1306015, 1306022, 1306104, 1306002, 1306009, 1306016, 1306023, 1306105, 1306003, 1306010, 1306017, 1306024, 1307100, 1306004, 1306011, 1306018, 1306100,  1307101, 1306005, 1306012, 1306019, 1306101, 1307102, 1306006, 1306013, 1306020, 1306102, 1317103.   2) Part Number: 31113.701; Serial Numbers: 11001, 11011, 11020, 11030, 11039, 11048, 11058, 11002, 11012, 11021, 11031, 11040, 11049, 11059, 11003, 11013, 11023, 11032, 11041, 11050, 11060, 11005, 11014, 11024, 11033, 11042, 11051, 11061, 11006, 11015, 11025, 11034, 11043, 11052, 11063, 11007, 11016, 11026, 11035, 11044, 11053, 11064, 11008, 11017, 11027, 11036, 11045, 11055, 11065, 11009, 11018, 11028, 11037, 11046, 11056, 11066, 11010, 11019, 11029, 11038, 11047, 11057, 11067.
Recalling Firm/
Manufacturer		 Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information Contact Customer Service
800-323-9653
Manufacturer Reason
for Recall		 The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
FDA Determined
Cause 2		 Device Design
Action Field Action Notice letters dated December 10, 2014 were sent to both direct accounts (customers). The letters instructed customers to: 1) Instruct the biomed to bypass the integrated power grid on the cart and not to use the electrical system on the affected carts until a qualified Omni Corporation service technician is able to inspect and repair the carts; and 2) Omni Corporation will schedule a qualified Omni field service technician, in conjunction with Richard Wolf and the customer's biomed unit, to visit and replace the transformer on the cart.
Quantity in Commerce 83 carts
Distribution Nationwide
Total Product Life Cycle TPLC 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.
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