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Recall Observatory FDA recall evidence

Device product

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

Z-1240-2015

December 10, 2014

Class II

Product summary

Firm
Richard Wolf Medical Instruments Corp.
Event
Event 70220
Status
Terminated
Classification
Class II
Quantity
83 carts
Official record key
device-enforcement:Z-1240-2015

Official wording

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 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.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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