Z-1240-2015Class II

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

Name: Z-1240-2015 The I-Cart is used to store, transport, and power video equipment used in medical procedures
Creator: Richard Wolf Medical Instruments Corp.
Published: 2014-12-10
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2014-12-10 / Terminated / root cause: design

FDA source

Richard Wolf Medical Instruments Corp. began a recall of The I-Cart is used to store, transport, and power video equipment used in medical procedures on 2014-12-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1240-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-10
Posted: 2015-03-03
Terminated: 2017-07-31
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Product code: KMI Monitor, Bed Patient
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1240-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1240-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-03

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)