Ventilator Operator's Guide Recalled for Missing Critical MRI Safety Information
ZOLL is recalling operator's guides for the ZOLL 731 Ventilator because they omit critical MRI safety information. Missing distance guidance could cause the ventilator to malfunction during MRI procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall; the agency's classification of Class I medical device recalls never falls below severity 4. Although no deaths or injuries are reported, the missing safety guidance for a life-support device during MRI procedures represents a serious operational hazard.
Plain-English summary
ZOLL Medical Corporation is recalling the Operator's Guide and Quick Reference Guide for the ZOLL 731 Ventilator. These critical documentation items (affecting 2,361 units) have been distributed worldwide, including throughout the United States and over 40 additional countries.
The recalled manuals omit essential information about safe distances from MRI machines. Although the ZOLL 731 is designed as MRI-compatible equipment, the operator's guides do not include the necessary safety instructions. Without proper guidance, clinical staff cannot ensure correct positioning of the ventilator during or near MRI procedures, creating risk of device malfunction, performance degradation, and potential delay in patient ventilator therapy.
Healthcare facilities should obtain the updated documentation from ZOLL Medical, which now includes the required MRI safety distance information. All clinical and technical staff should be informed of the hazard and provided with the corrected guides.
The recalled product
- Product
- ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Ventilator
- Hazard
- missing-documentation
- mri-interference
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 9650-002365-01 (US)
- 906-0731-01-05 (CAN)
- 906-0731-01-10
- 9650-0002363-01
- 906-0731-01 (Commercial)
- 906-0731-03 (Military)
- 9650-0002363-05
- 906-0731-01
- 906-0731-01-04
- 906-0731-01-05
- 906-0731-01-08
- 906-0731-01-11
- 906-0731-01-15
- 906-0731-01-16
- 9650-0002363-02
- 9650-0002363-08
- 9650-0002363-10
- 9650-0002363-11
- 9650-0002363-12
- 9650-0002363-16
Distribution
Distributed nationwide across the United States.
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