Reported Nov 11, 2015 · Terminated
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- MR Surgical Suite II Table
- Model Number(s)
M8074SSM8053SSM0074SS
- UPDATE 11-4-2015Model M0001SS
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 00000013254M6808244516001400001309FMM07L T4185506 DUMFMI60876024 M347028301 00000021695M62 M4194477 00000305145MR5 UC2547MR01 00001219FMM0H1 EM0105 00001105XF5047 PL2853MR01 00001251FMM044 34368MRS01 UPDATE 11-4-2015: Mfg Lot or Serial # System ID 2 602406IMR 3 507284NMRV N/A 214820ITABLE N/A 416369MR3T 000000PTST0008082427040101— 000000PTST0007082427050024000000PTST0003 CS1020MR01 N/A CS1006MR03 4 YM1733 000000PTST0010 YM3833 000000PTST0006 ZA2169MR01 000000PTST0005 10590MRS01 - Amount recalled
- 23 (11 US; 12 OUS) Update 11-4-2015: 35 (14 US; 21 OUS)
Where it was sold
Why it was recalled
GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. The issue may prevent patient transfer between the MR and surgical tables.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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