CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Imri Short Hd Attachment recalled by The Anspach Effort
The Anspach Effort is recalling Imri Short Hd Attachment, distributed nationwide in the US. The recall was initiated on 6 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1998-2017
- FDA event ID
- 76059
- Recalling firm
- The Anspach Effort, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2016
- FDA classified
- 4 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 6 Oct 2016 | Recall initiated by company | |
| 4 May 2017 | Classified by FDA | +210 days |
| 10 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product as listed by the FDA
IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
Where it was distributed
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Questions about this recall
Is Imri Short Hd Attachment recalled?
Yes. The Anspach Effort recalled Imri Short Hd Attachment on 6 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-1998-2017.
Why was it recalled?
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Which lots are affected?
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT-HD.
Where was it sold?
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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