Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 19, 2017
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare, LLC recalled Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 - a moderate-severity action.
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 was recalled by Ge Healthcare, LLC in July 19, 2017. Reason: Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction. Check the official notice for the remedy. Verify recall #Z-2703-2017 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction.
- Moderate
- severity level
- Class II
- classification
- July 19, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2703-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2703-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on May 2, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 3,448 (334 US; 3,114 OUS).
The documented reason for this recall is: Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction Distribution data in the federal record shows the product reached: US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria A…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,448 (334 US; 3,114 OUS)
Related Recalls
6
3 from same agency
Product description
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Reason for recall
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2703-2017 |
| Date reported | July 19, 2017 |
| Date initiated | May 2, 2017 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 3,448 (334 US; 3,114 OUS) |
| Distribution | US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2703-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1. Recalled by Ge Healthcare, LLC. Units affected: 3,448 (334 US; 3,114 OUS).
Why was this product recalled? ▼
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2703-2017.
Where was the recalled product distributed? ▼
Distribution: US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d'Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kenya Korea (Republic Of) Kuwait Latvia Lebanon Lithuania Malaysia Maldives Malta Mauritius Mexico Moldova Morocco Myanmar Netherlands New Zealand Nigeria Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2703-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 19, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.