Z-1240-2015 Class II Terminated
FDA device recall Z-1240-2015 was initiated by Richard Wolf Medical Instruments Corp. on December 10, 2014 and is designated Class II. 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. The recall status is terminated (terminated July 31, 2017). Affected quantity: 83 carts.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2015
- Initiation Date
- December 10, 2014
- Termination Date
- July 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 carts
Product Description
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
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.
Distribution Pattern
Nationwide
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.