Reported Jul 3, 2024 · Ongoing
CARESCAPE B650
GE Healthcare Finland Oy
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 Healthcare Finland Oy · Kuortaneenkatu 2 · Helsinki · N/A
Is this the product you have?
CARESCAPE B650
145 of 145 products
| Model / number | Product as published |
|---|---|
2095801-001 | CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) |
2095801-001-01018416 | 2) |
2095801-001-01023150 | 3) |
2095801-001-01023151 | 4) |
2095801-001-01023152 | 5) |
2095801-001-01032962 | 6) |
2095801-001-01033915 | 7) |
2095801-001-01034302 | 8) |
2095801-001-01034399 | 9) |
2095801-001-01034528 | 10) |
2095801-001-01034573 | 11) |
2095801-001-01035087 | 12) |
2095801-001-01036384 | 13) |
2095801-001-01037712 | 14) |
2095801-001-01038022 | 15) |
2095801-001-01038593 | 16) |
2095801-001-01041035 | 17) |
2095801-001-01041611 | 18) |
2095801-001-01041694 | 19) |
2095801-001-01042512 | 20) |
- Lot codes and dates
160 of 160 products
Products covered by this recall # Product as published 1 MBB313 2 2095801-001, Serial Numbers: STF21330010HA, STF21330023HA, STF21400190HA, SNS20303110SA, SNS20363001SA, SNS20392015SA, SS620481053HA 3 2095801-001-01018416, Serial Numbers: STF22200047HA, STF22200048HA, STF22200061HA, STF22200062HA, STF22200065HA, STF22200066HA, STF22200067HA, STF22200068HA, STF22200069HA, STF22200070HA, STF22200071HA, STF22200072HA, STF22200073HA, STF22200074HA, STF22200075HA, STF22200079HA 4 2095801-001-01023150, Serial Numbers: STF22311034HA, STF22311035HA, STF22311036HA, STF22311037HA 5 2095801-001-01023151, Serial Numbers: STF22311021HA, STF22311022HA, STF22311023HA, STF22311024HA, STF22311025HA, STF22311026HA, STF22311027HA, STF22311028HA, STF22311030HA, STF22311039HA, STF22311040HA, STF22311041HA, STF22311042HA, STF22311043HA, STF22311044HA, STF22311045HA, STF22311046HA, STF22311047HA, STF22311048HA, STF22311049HA, STF22311050HA, STF22311051HA, STF22311052HA, STF22311053HA, STF22311054HA, STF22311055HA, STF22311056HA, STF22311057HA, STF22311058HA, STF22311059HA, STF22311060HA, STF22311061HA, STF22311062HA, STF22311063HA, STF22311066HA, STF22311067HA, STF22311068HA, STF22311069HA, STF22311070HA, STF22311073HA, STF22311074HA, STF22311075HA, STF22311076HA, STF22311077HA, STF22311078HA, STF22311079HA, STF22311080HA, STF22311081HA, STF22311082HA, STF22311083HA, STF22311084HA, STF22311085HA, STF22311086HA, STF22311087HA, STF22311088HA, STF22311089HA, STF22311090HA 6 2095801-001-01023152, Serial Numbers: STF22311072HA 7 2095801-001-01032962, Serial Numbers: STF22280028HA, STF22280030HA, STF22200081HA, STF22270041HA, STF22270042HA, STF22450110HA, STF22450137HA, STF22200076HA, STF22200083HA, STF22200077HA, STF22250053HA, STF22250054HA, STF22250055HA, STF22250056HA, STF22260003HA, STF22270079HA, STF22250057HA, STF22270076HA, STF22270078HA, STF22200078HA, STF22200080HA, STF22200082HA 8 2095801-001-01033915, Serial Numbers: STF22312001SA, STF22312002SA, STF22312003SA, STF22312004SA, STF22312005SA, STF22312006SA, STF22312007SA, STF22312008SA, STF22312009SA, STF22312010SA, STF22312011SA, STF22312012SA, STF22312013SA, STF22312014SA, STF22312015SA, STF22312016SA, STF22312017SA, STF22312018SA, STF22312019SA, STF22312020SA, STF22312021SA, STF22312022SA, STF22312023SA, STF22312024SA, STF22312025SA, STF22312026SA, STF22312027SA, STF22312028SA, STF22312029SA, STF22312030SA, STF22312032SA, STF22312033SA, STF22312034SA, STF22312035SA, STF22312036SA, STF22312037SA, STF22312040SA, STF22312042SA, STF22312043SA, STF22312044SA, STF22312045SA, STF22312047SA 9 2095801-001-01034302, Serial Numbers: STF22440044HA 10 2095801-001-01034399, Serial Numbers: STF22200031HA, STF22200032HA, STF22200033HA, STF22200034HA, STF22200035HA, STF22200036HA, STF22200037HA, STF22200038HA, STF22200039HA, STF22200040HA 11 2095801-001-01034528, Serial Numbers: STF22302058SA 12 2095801-001-01034573, Serial Numbers: STF23082005SA, STF23082016SA 13 2095801-001-01035087, Serial Numbers: STF22262081SA 14 2095801-001-01036384, Serial Numbers: STF22392161SA, STF22392162SA, STF22402003SA, STF22402004SA, STF22402005SA, STF22402006SA, STF22402008SA, STF22402009SA, STF22402010SA, STF22402011SA, STF22402012SA, STF22402013SA, STF22402014SA, STF22402015SA, STF22402016SA, STF22402017SA, STF22402018SA, STF22402019SA 15 2095801-001-01037712, Serial Numbers: SNS22292010SA 16 2095801-001-01038022, Serial Numbers: STF22262087SA 17 2095801-001-01038593, Serial Numbers: STF22510003HA, STF22510011HA, STF22510012HA, STF22510013HA, STF22510014HA, STF22510015HA, STF22510016HA, STF22510017HA, STF22510018HA, STF22510019HA, STF22510020HA, STF22250013HA, STF22250014HA, STF22250015HA, STF22270071HA, STF22270073HA, STF22300024HA, STF22300027HA 18 2095801-001-01041035, Serial Numbers: STF22452107SA, STF22452108SA, STF22452112SA, STF22452114SA, STF22452115SA, STF22452116SA, STF22462002SA, STF22462003SA, STF22462004SA 19 2095801-001-01041611, Serial Numbers: STF22322093SA, STF22322096SA, STF22322098SA, STF22322099SA, STF22322106SA, STF22322127SA, STF22322128SA, STF22322130SA, STF22322132SA, STF22322135SA, STF22322136SA, STF22322137SA, STF22322140SA, STF22332001SA, STF22332002SA, STF22332003SA, STF22332004SA, STF22332005SA, STF22332006SA, STF22332007SA, STF22332008SA, STF22332009SA, STF22332011SA, STF22332012SA, STF22392134SA, STF22392135SA, STF22392139SA, STF22392149SA, STF22392156SA, STF22392157SA, STF22392166SA, STF22392188SA, STF22392189SA, STF22392190SA, STF22392192SA, STF22392193SA, STF22392136SA, STF22392147SA, STF22392148SA, STF22392153SA, STF22392154SA, STF22392163SA, STF22392165SA, STF22392168SA, STF22392169SA, STF22392172SA, STF22392191SA, STF22392195SA 20 2095801-001-01041694, Serial Numbers: STF22392137SA, STF22392138SA, STF22392140SA, STF22392141SA, STF22392145SA, STF22392146SA, STF22392150SA, STF22392151SA, STF22392152SA, STF22392155SA, STF22392158SA, STF22392159SA, STF22392167SA, STF22392170SA, STF22392171SA - Amount recalled
- 54800 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
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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