Reported Jul 3, 2024 · Ongoing
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017,…
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?
158 of 158 products
| # | Product as published |
|---|---|
| 1 | MBC303, Model Numbers |
| 2 | 2078633-001 |
| 3 | 2078633-010 |
| 4 | 2078633-012 |
| 5 | 2078633-017 |
| 6 | 2078633-028 |
| 7 | 2095802-001-54069330 |
| 8 | 2095802-001-554922 |
| 9 | 2095802-001-554923 |
| 10 | 2095802-001-554924 |
| 11 | 2095802-001-554925 |
| 12 | 2095802-001-554926 |
| 13 | 2095802-001-554927 |
| 14 | 2095802-001-554928 |
| 15 | 2095802-001-555120 |
| 16 | 2095802-001-556223 |
| 17 | 2095802-001-557346 |
| 18 | 2095802-001-558678 |
| 19 | 2095802-001-558707 |
| 20 | 2095802-001-559208 |
- Lot codes and dates
157 of 157 products
Products covered by this recall Model / number Barcodes Product as published MBC303— — 2078633-001, UDI/DI none, Serial Numbers: 2293663-1-1 — 2078633-010, UDI/DI none, Serial Numbers: 2284163-2-1, 2284112-3-1, 2284163-1-1, 2284112-4-1, 2262484-1-1, 2262484-1-2 — 2078633-012, UDI/DI none, Serial Numbers: 2400553-4-1, 2266860-3-2 — 2078633-017, UDI/DI none, Serial Numbers: 2261264-2-1, 2290421-2-1, 2288663-1-1, 2290422-2-1, 2312000-3-1, 2311672-4-1, 2311672-5-1, 2320320-1-1, 2284038-3-1, 2329280-2-1 — 2078633-028, UDI/DI none, Serial Numbers: 2426418-2-1, 2450634-2-1, 2501447-2-1, 2426426-25-1, 2428347-1-1, 2460598-2-1, 2405070-10-1, 2426421-3-1, 2460618-6-1, 2583610-13-1, 2426425-5-1, 2428332-1-1, 2428345-1-1, 2460628-7-1, 2403419-9-1, 2426423-4-1, 2501439-13-1, 2409922-12-1, 2423627-1-1, 2460617-1-1, 2501399-4-1, 2501446-13-1, 2445364-1-1, 2465141-1-1 — 008406821367232095802-001-54069330, UDI/DI 00840682136723, Serial Numbers: SNR19110001HA, SNR19110005HA, SNR19110002HA, SNR19110003HA, SNR19110004HA — 008406821367232095802-001-554922, UDI/DI 00840682136723, Serial Numbers: SNR18060001HA, SNR18060003HA, SNR18060005HA, SNR18060006HA, SNR18060007HA, SNR18060012HA, SNR18060013HA, SNR18060014HA, SNR18060015HA, SNR18060016HA, SNR18060017HA, SNR18010010HA, SNR18010012HA, SNR18010021HA — 008406821367232095802-001-554923, UDI/DI 00840682136723, Serial Numbers: SNR18060011HA, SNR18060022HA, SNR18060028HA, SNR18060029HA, SNR18060031HA, SNR18060032HA, SNR18060036HA, SNR18070001HA, SNR18070003HA, SNR18070008HA, SNR18070012HA, SNR18070013HA, SNR18070014HA, SNR18070018HA, SNR18070019HA, SNR18070020HA, SNR18070021HA, SNR18070022HA, SNR18070023HA, SNR18070024HA, SNR18070025HA, SNR18070026HA, SNR18070027HA, SNR18070028HA, SNR18070029HA, SNR18070030HA, SNR18070031HA, SNR18070032HA, SNR18070033HA, SNR18070037HA, SNR18070038HA, SNR18070039HA, SNR18070040HA, SNR18070045HA, SNR18070046HA, SNR18070052HA, SNR19030080HA, SNR19030081HA, SNR19030082HA, SNR19030083HA, SNR19030084HA, SNR19030091HA, SNR19040002HA, SNR19040003HA, SNR19040004HA, SNR19040005HA, SNR19040006HA, SNR19040007HA, SNR18070007HA, SNR18080007HA, SNR18370013HA, SNR18070016HA, SNR18070017HA, SNR19030085HA — 008406821367232095802-001-554924, UDI/DI 00840682136723, Serial Numbers: SNR18010004HA, SNR18010011HA, SNR18020001HA — 008406821367232095802-001-554925, UDI/DI 00840682136723, Serial Numbers: SNR18070076HA, SNR18070077HA, SNR18070078HA, SNR18070079HA, SNR18070080HA, SNR18070081HA, SNR18070082HA, SNR18070083HA, SNR18070084HA, SNR18070085HA, SNR18070086HA, SNR18070089HA, SNR18070090HA, SNR18080001HA, SNR18080002HA, SNR18080003HA, SNR18390025HA, SNR18390027HA, SNR18400032HA, SNR18400033HA, SNR18400035HA, SNR18400037HA, SNR18400045HA, SNR18400046HA, SNR18400047HA, SNR18400053HA, SNR18400066HA, SNR19190046HA, SNR19190047HA, SNR19190048HA, SNR19190049HA, SNR19190050HA, SNR19190051HA, SNR19190052HA, SNR19190053HA, SNR18010001HA, SNR18010003HA, SNR18010013HA, SNR18010014HA, SNR18010020HA, SNR18010028HA, SNR18010029HA, SNR18020002HA — 008406821367232095802-001-554926, UDI/DI 00840682136723, Serial Numbers: SNR18060002HA, SNR18060008HA, SNR18060009HA, SNR18060010HA, SNR18060018HA, SNR18060019HA, SNR18060020HA, SNR18060021HA, SNR18060023HA, SNR18060024HA, SNR18060025HA, SNR18060026HA, SNR18060027HA, SNR18060030HA, SNR18060033HA, SNR18060034HA, SNR18060035HA, SNR18070002HA, SNR18070005HA, SNR18070006HA, SNR18070009HA, SNR18070010HA, SNR18070011HA, SNR19030086HA, SNR19030087HA, SNR19030088HA, SNR19030089HA, SNR19030090HA, SNR19030092HA, SNR19030093HA, SNR19030094HA, SNR19030095HA, SNR19030096HA, SNR19030097HA, SNR19030098HA, SNR19030099HA, SNR19030100HA, SNR19030101HA, SNR19030102HA, SNR19030103HA, SNR19040019HA, SNR19040037HA, SNR19040038HA, SNR19040039HA, SNR19040050HA, SNR19040051HA, SNR18010002HA, SNR18010005HA, SNR18010009HA, SNR18010018HA, SNR18010027HA — 008406821367232095802-001-554927, UDI/DI 00840682136723, Serial Numbers: SNR18010006HA, SNR18010023HA, SNR18010024HA, SNR18010025HA, SNR18010026HA, SNR18010016HA — 008406821367232095802-001-554928, UDI/DI 00840682136723, Serial Numbers: SNR18070041HA, SNR18070042HA, SNR18070043HA, SNR18070044HA, SNR18070047HA, SNR18070048HA, SNR18070064HA, SNR18070065HA, SNR18070066HA, SNR18070067HA, SNR18070068HA, SNR18070073HA, SNR18070074HA, SNR18070075HA, SNR18080004HA, SNR18080005HA, SNR18160046HA, SNR18180021HA, SNR18380012HA — 008406821367232095802-001-555120, UDI/DI 00840682136723, Serial Numbers: SNR18070015HA, SNR18070035HA, SNR18070036HA, SNR18070049HA, SNR18070050HA, SNR18070054HA, SNR18070055HA, SNR18070056HA, SNR18070057HA, SNR18070060HA, SNR18070087HA, SNR18070091HA — 008406821367232095802-001-556223, UDI/DI 00840682136723, Serial Numbers: SNR18180048HA, SNR18330090HA, SNR18360020HA, SNR18360025HA, SNR18360026HA, SNR18360055HA, SNR18360021HA, SNR18360023HA, SNR18070069HA, SNR18070070HA, SNR18070071HA, SNR18070072HA — 008406821367232095802-001-557346, UDI/DI 00840682136723, Serial Numbers: SNR18010017HA — 008406821367232095802-001-558678, UDI/DI 00840682136723, Serial Numbers: SNR18010030HA, SNR18010019HA, SNR18100006HA, SNR18100007HA, SNR18180040HA, SNR18180041HA, SNR18180044HA, SNR18180047HA, SNR18180049HA, SNR18190004HA, SNR18190007HA, SNR18010015HA — 008406821367232095802-001-558707, UDI/DI 00840682136723, Serial Numbers: SNR18080010HA, SNR18080028HA, SNR18100005HA — 008406821367232095802-001-559208, UDI/DI 00840682136723, Serial Numbers: SNR18080018HA, SNR18080012HA, SNR18080011HA - Amount recalled
- 25268 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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