Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 6, 2013
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." Th…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Medical Systems USA recalled MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for:… - a moderate-severity action.
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for:… was recalled by Maquet Medical Systems USA in November 6, 2013. Reason: It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an…. Check the official notice for the remedy. Verify recall #Z-0082-2014 with the FDA Devices before acting.
The recall
Maquet Medical Systems USA issued this moderate-severity FDA Devices recall-It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an….
- Moderate
- severity level
- 63 units
- affected scope
- Class II
- classification
- November 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0082-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0082-2014) was formally reported on November 6, 2013, with the manufacturer initiating the action on September 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Maquet Medical Systems USA is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 63.
The documented reason for this recall is: It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when… Distribution data in the federal record shows the product reached: Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO. 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
63
Related Recalls
6
3 from same agency
Product description
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
Reason for recall
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0082-2014 |
| Date reported | November 6, 2013 |
| Date initiated | September 12, 2013 |
| Recalling firm | Maquet Medical Systems USA |
| Firm location | Wayne, NJ |
| Affected scope | 63 |
| Distribution | Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO |
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-0082-2014) 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? ▼
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.. Recalled by Maquet Medical Systems USA. Units affected: 63.
Why was this product recalled? ▼
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0082-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0082-2014) 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 November 6, 2013. 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.