CLASS II ONGOING Device recall · Reported 3 Jul 2019 · FDA Enforcement Report
TASE 500 Imaging systems recalled by Collins Aerospace
Collins Aerospace is recalling TASE 500 Imaging systems, distributed nationwide in the US. The recall was initiated on 29 Jan 2019 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-1784-2019
- FDA event ID
- 82988
- Recalling firm
- Collins Aerospace, Westford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2019
- FDA classified
- 27 Jun 2019
- Reported
- 3 Jul 2019
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 29 Jan 2019 | Recall initiated by company | |
| 27 Jun 2019 | Classified by FDA | +149 days |
| 3 Jul 2019 | 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
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
Product as listed by the FDA
TASE 500 Imaging systems
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is TASE 500 Imaging systems recalled?
Yes. Collins Aerospace recalled TASE 500 Imaging systems on 29 Jan 2019. The recall is Class II and its status is Ongoing. Recall number Z-1784-2019.
Why was it recalled?
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
Which lots are affected?
TASE 500
Where was it sold?
US Nationwide Distribution
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.
More recalls from Collins Aerospace
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