# FDA recall Z-2168-2024

> **GE Healthcare Finland Oy** · Class II · device recall initiated 2024-04-05.

## Product

CARESCAPE Canvas 1000, Model Numbers:   a)	5865770;  b)	5865770-01040169;  c)	5865770-01054142;  d)	5865770-01054696;  e)	5865770-01054698;  f)	5865770-01054721;  g)	5865770-01054740;  h)	5865770-01055202;  i)	5865770-01055204;  j)	5865770-01055270;  k)	5865770-01055317;  l)	5865770-01055796;  m)	5865770-01058501;  n)	5865770-01058596;  o)	5865770-01058597;  p)	5865770-01059641;  q)	5865770-01062146;  r)	5865770-01065501;  s)	5865770-01065702;  t)	5865770-01065703;  u)	5865770-01065739;  v)	5865770-01065740;  w)	5865770-01074051;  x)	5865770-01074386;  y)	5865770-01076001;  z)	5865770-01077195;  aa)	5865770-01077196;  bb)	5865770-01079968;  cc)	5865770-01080218;  dd)	5865770-01080222;  ee)	5865770-01080227;  ff)	5865770-01080925;  gg)	5865770-01080960;  hh)	5865770-01081316;  ii)	5865770-01081386;  jj)	5865770-01083664;  kk)	5865770-01085971;  ll)	5865770-01086005;  mm)	5865770-01086006;  nn)	5865770-01086160;  oo)	5865770-01086235;  pp)	5865770-01086558;  qq)	5865770-01086633;  rr)	58

## Reason for recall

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.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2168-2024
- **Recalling firm:** GE Healthcare Finland Oy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-05
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Helsinki, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2168-2024

## Citation

> AI Analytics. FDA recall Z-2168-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2168-2024. Source: US FDA. Licensed CC0.

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