Z-1211-2013Class II

MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial...

Name: Z-1211-2013 MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial...
Creator: GE Healthcare, LLC
Published: 2013-03-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-03-28 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal... on 2013-03-28. FDA classified it as Class II and gives the reason as "Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1211-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-05-01
Terminated: 2013-10-25
Recalling firm: GE Healthcare
Product: MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated April 23, 2013, to all affected customers. The letter informed customers of a potential safety issue due to leakage from gradient coolant lines. Consignees were instructed to monitor the floor for leakage and continue to use if leakage is not observed. If leakage is observed consignees are instructed to stop using the system and notify their local service representative. GE Healthcare will correct all affected scanners by providing an update at no cost. Customers with questions were instructed to contact their local service representataive. For questions regarding this recall call 262-513-4122.
Quantity in commerce: 70
Distribution: Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
Product codes and lots: 01072011-001; 01082010-001; 01182010-001; 01182011-001; 01272010-001; 02032011-001; 02112010-001; 02182011-001; 02242010-001; 2262011-001; 03012010-001; 03072010-001; 03132009-001; 03242009-001; 03292011-001; 03302011-001; 04012010-001; 04082010-001; 04192011-001; 04202011-001; 04302010-001; 05072010-001; 05132011-001; 05152009-001; 05242010-001; 05262010-001; 06012008-001; 06042009-001; 06062009-001; 06082010-001; 06182010-001; 06192009-001; 07082010-001; 07092010-001; 07142009-001; 07152011-001; 07272010-001; 08082009-001; 08122009-001; 08122010-001; 08132009-001; 08152010-001; 09072009-001; 09132010-001; 09142010-001; 09172009-001; 09222009-001; 09222010-001; 10012009-001; 10082009-001; 10082010-001; 10142009-001; 10182010-001; 10222010-001; 10252009-001; 10312010-001; 11162010-001; 11242009-001; 11292010-001; 12052010-001; 12072009-001; 12142009-001; 12152009-001; 12162008-001; 12182008-001; 12222010-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1211-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1211-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-01
Z-1212-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-01

Product code LNH

K080048Class IIMsk Extreme Mr Scanner, Model Aa5000Oni Medical Systems, Inc. / cleared 2008-02-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)