FDA Enforcement Class II Terminated

The I-Cart is used to store, transport, and power video equipment used in medical procedures.

Recall: Z-1240-2015 · Reported March 11, 2015

Enforcement

Recall Number
Z-1240-2015
Event ID
70220
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Richard Wolf Medical Instruments Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 11, 2015
Initiation Date
December 10, 2014
Classification Date
March 3, 2015
Termination Date
July 31, 2017
Address
353 Corporate Woods Pkwy, N/A, Vernon Hills, IL, 60061-3110, United States

Description

The I-Cart is used to store, transport, and power video equipment used in medical procedures.

Reason

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.

Code Info

(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.

Distribution

Nationwide

Quantity

83 carts